SENIOR BIOSTATISTICIAN JOB DESCRIPTION

Statistical analysis plans do not write themselves, and when they are missing rigor, Phase I-IV submissions stall at the FDA. The Senior Biostatistician owns the analytical backbone of clinical trial operations - producing SAPs, integrated summaries of efficacy and safety, and randomization schedules that regulatory agencies and internal study teams depend on to advance a compound. A senior seat. Real accountability. The role reports into biometrics or biostatistics leadership and interacts directly with sponsors, CRO partners, IRBs, and regulatory authority reviewers navigating ICH E9 and CDISC compliance standards.

As the Senior Biostatistician, you lead statistical strategy and deliverable production across Phase I-IV clinical studies, owning analysis plan development, sample size calculations, and the statistical integrity of regulatory submission packages. You operate within a biometrics department or CRO study team, collaborating with clinical data managers, statistical programmers, and sponsor biostatistics management to keep study timelines and quality standards on track.

Career Impact: Serving as lead biostatistician on NDA-level protocols builds the kind of regulatory-facing experience that distinguishes a statistician's profile across the pharma and biotech hiring market.

Business Impact: When SAPs, TLGs, and integrated efficacy summaries are accurate and submission-ready, sponsors can move compounds through regulatory review without costly delays or complete-response letters.

Growth Opportunity: Exposure to Bayesian adaptive designs, real-world evidence methods, and machine learning applications in clinical research expands your methodological range well beyond traditional frequentist trial work.

• Lead development of statistical analysis plans for Phase I-IV trials, including table and listing specifications and randomization documentation.
• Review sample size calculations and protocol statistical sections for clinical soundness and regulatory alignment.
• Direct production and quality control of analysis datasets, TLGs, and integrated summaries of safety and efficacy for regulatory submissions.
• Oversee collaboration with statistical programmers and clinical data managers on database structure, maintenance, and analysis-ready dataset delivery.
• Represent the biostatistics function in meetings with sponsors, IRBs, and regulatory authorities on statistical methodology and submission strategy.
• Mentor junior biostatisticians in the application of advanced statistical methodologies and standard operating procedures.
• Audit statistical analysis plans, derived datasets, and study reports to ensure compliance with GCP, ICH, and CDISC standards.
• Prepare statistical sections of clinical study reports and manuscripts, incorporating results interpretation for cross-functional audiences.

• Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field, or equivalent work experience.
• 5 or more years of biostatistics experience in pharmaceutical, biotech, or CRO clinical development, with demonstrated lead-level accountability.
• Proven ability to develop and execute statistical analysis plans independently across multiple concurrent clinical protocols.
• Working knowledge of CDISC SDTM and ADaM data standards and their application to clinical trial datasets.
• Strong understanding of FDA, ICH, and GCP regulatory requirements governing the design and analysis of clinical trials.
• Demonstrated experience preparing or contributing to regulatory submission packages, including integrated summaries of safety and efficacy.
• Ability to communicate complex statistical methodology clearly to clinical, regulatory, and non-statistical stakeholders.
• Strong project management capability, with a track record of meeting quality standards and delivery timelines across parallel studies.

• Experience with Bayesian adaptive trial designs or simulation-based sample size methods in late-phase pharmaceutical development.
• Familiarity with real-world evidence study designs, including propensity score methods or time-to-event analyses in observational datasets.
• Prior experience functioning as the unblinded biostatistician or statistical lead on Data Safety Monitoring Board reporting teams.
• Background in a specialized therapeutic area such as oncology, immunology, infectious disease, or rare disease clinical trials.

• SAP completion rate on schedule, measured against protocol-locked timelines across assigned studies.
• Regulatory submission acceptance rate, reflecting the technical accuracy of integrated summaries and e-submission packages.
• TLG quality control pass rate, tracking the proportion of tables and figures cleared without revision requests from sponsors or reviewers.
• Audit finding rate per study, measuring compliance with GCP, ICH, and CDISC standards across statistical deliverables.
• Mentor throughput, measured by junior biostatistician advancement and independence on assigned tasks over a 12-month period.
• Typical tools: Statistical computing (commonly SAS and R); data standards platforms (commonly CDISC-compliant ADaM and SDTM environments)

• Base Salary Range: $115,000 to $165,000 annually, depending on seniority and location
• Bonus: 8 to 15 percent annual performance bonus, common in pharma and CRO settings
• Equity: stock options or RSUs offered at biotech and mid-to-large pharma employers
• Health Benefits: medical, dental, and vision coverage, typically employer-subsidized
• PTO: 15 to 25 days annually, plus company holidays and sick leave
• Common Perks: Conference attendance support, continuing education reimbursement, remote or hybrid work options

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Candidates for this position are considered without regard to race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected under applicable federal, state, and local law. Reasonable accommodations are available to qualified individuals with disabilities throughout the application and employment process upon request. Background checks are a standard condition of employment for roles involving regulatory data and submission responsibilities. Applicants must be authorized to work in the United States.

The Senior Biostatistician delivers statistical leadership across preclinical development plans, concept sheets, protocols, and regulatory submission dossiers, including leading electronic data submissions to regulatory authorities. Collaborating with sponsor cross-functional teams and Biostatistics management, this role shapes the use of innovative statistical methodologies to advance product development programs.

Key Responsibilities

• Provide statistical leadership and expertise into preclinical development plans, concept sheets and protocols for product development projects.
• Contribute to the development of sourcing strategy for projects.
• Write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Review and contribute to study reports and exploratory/preclinical statistical sections of regulatory submission dossiers.
• Lead electronic submissions of preclinical data to regulatory authorities and participate in meetings with regulatory authorities.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
• Provide input into statistical standard operating procedures and general standardization efforts.
• Mentor and develop statistical colleagues.

Required Qualifications

• PhD or MS in Statistics, Biostatistics or related discipline.
• At least 5 (PhD) or 7 (MS) years of experience as biostatistician in the pharmaceutical or biotechnology industry in preclinical development.
• Experience in Oncology, Immuno-oncology, Vaccines therapeutic areas and with exploratory/clinical biomarkers.
• Knowledge of relevant international regulatory guidelines applicable to clinical development and experience with regulatory interactions and data e-submission to FDA.
• Expert programmer in R with working knowledge of SAS, JMP and GraphPad Prism.
• Works effectively in international teams and within a matrix organization with multi-disciplinary groups.
• Excellent time management with ability to balance concurrent tasks and responsibilities.
• Fluency in English and knowledge of other languages. 

Embedded within the biostatistics department, the Senior Biostatistician independently provides statistical consulting and assists with study design and protocol development, including preparing statistical analysis plans and generating TLGs for clinical study reports. Working closely with data management and clinical teams, this role ensures regulatory-compliant deliverables through advanced SAS programming and rigorous quality control of analysis datasets.

Core Functions

• Provide statistical consulting independently and assist with study design and protocol development.
• Prepare statistical sections of protocols and perform sample size and power calculations for studies.
• Review protocols, case report forms, data management plans, data specifications and other related study documents.
• Develop statistical analysis plans in accordance with protocols and SAS programs to complete statistical analyses.
• Support integrated summaries of safety and efficacy for regulatory submissions.
• Prepare analysis data specifications and develop SAS programs to create derived variables and analysis datasets.
• Generate listings, tables and graphs using SAS and perform quality control of analysis data and TLGs.
• Prepare statistical reports and review and interpret analysis results for clinical study reports.

Qualifications and Experience

• Advanced degree (MS or PhD) in Statistics or closely related field.
• Direct advanced knowledge of clinical trials design and analysis with advanced SAS programming experience.
• Working knowledge of CDISC standards and application of those standards to projects.
• Demonstrated knowledge of design of clinical trials, regulatory requirements and advanced SAS macro development.
• Detail oriented, well organized with ability to work on several projects simultaneously.
• Excellent English communication skills, verbal, written and interpersonal.

Reporting to senior research leadership, the Senior Biostatistician develops statistical and biological knowledge to support researchers across the non-clinical arena, identifying and delivering innovative solutions for key biological questions through statistics. Partnering with scientists, external collaborators, and stakeholders across the organization, this role advances statistical capabilities and drives impact through publications, presentations, and local and global project leadership.

Primary Duties

• Develop statistical and biological knowledge to support researchers across the non-clinical arena.
• Identify and deliver solutions for addressing key biological questions through statistics.
• Build relationships with stakeholders to demonstrate value of statistics across the organization.
• Communicate statistical concepts and results to engage a diverse audience.
• Improve the underlying statistical capabilities and awareness of stakeholders.
• Contribute to and lead both local and global projects.
• Engage with external collaborators via publications and presentations.
• Identify areas of impact and propose innovative statistical solutions independently.

Skills and Qualifications

• Masters in Biostatistics, Data Science or equivalent experience, with a degree in a biology related subject.
• Experience in applying statistics to biological problems and in exploring and optimizing experimental design.
• Previous consulting experience and general knowledge of the drug research and development process.
• Programming experience with R, Python or similar.
• Excellent oral and written communication skills, especially when communicating statistical concepts to non-statisticians.

Sitting at the intersection of computational science and drug development, the Senior Biostatistician applies and develops analytical methods and predictive models that deliver impact on research programs, including expertise in machine learning, deep learning, and large-scale omics data analytics. Operating across bioinformatics, statistical genetics, and clinical trial dataset analysis, this role builds quality benchmarks for data and models in close collaboration with scientific users.

Duties

• Confirm that team members understand the addressed scientific questions and the data interpretation.
• Apply and develop analytical methods and predictive models that deliver impact on research and drug development programs.
• Contribute to the identification and preparation of chem/biomedical datasets for application.
• Develop key results and quality benchmarks for data, models and impact in collaboration with scientific users.
• Create approaches, methods and models iteratively and communicate results effectively to non-data scientist associates.
• Apply expertise in machine learning, deep learning, data visualization and structured/unstructured data analytics toward scientific goals.

Experience and Qualifications

• PhD in a quantitative or computational science such as Bioinformatics, Machine Learning, Statistics, Physics or Mathematics.
• Expertise in two or more of: Computational Biology and Statistical Genetics, Applied Data Science and Large-Scale Computation, Statistical and Machine/Deep Learning, or Analysis of Clinical Trial Datasets and RWE Data.
• Strong experience with Python and R for data analysis.
• Experience with computational environments for large-scale data science such as High-Performance Computing or Spark, and reproducible data science using notebooks and git.
• Knowledge of Bioinformatics around DNA, RNA or Proteomics data analysis and/or Statistical Genetics.
• Awareness of statistical and machine or applied deep learning methods for time series data or images.
• Proficiency in English alongside multilingual capabilities. 

A key member of the biostatistics and biometrics department, the Senior Biostatistician leads complex statistical analyses and develops analysis strategies executed through efficient SAS and R programming for clinical and observational studies. Collaborating across biostatistical and company departments, this role coordinates project activities within budget and timelines while mentoring junior staff and representing the organization at client meetings.

Functions

• Supervise complex statistical analyses and provide input to statistical reports.
• Develop complex analysis strategies and execute them using efficient programming techniques.
• Provide expert input to analysis plans, statistical reports and statistical sections of integrated clinical reports.
• Act as a proactive advisor for all types of analysis during the proposal process and throughout the project lifecycle.
• Review analysis datasets and quality control all types of statistical analysis deliverables.
• Cooperate with other biostatistical and company departments to optimize global efficiency.
• Coordinate biostatistics-related project activities for successful completion within given timelines and budget.
• Interact with clients regarding data analysis, scope of work and budget, and represent the company at client meetings.
• Train and mentor junior members of the department.

Requirements

• PhD or Masters in a statistical discipline with sufficient work experience.
• A thorough understanding of the statistical aspects of clinical trials and/or observational studies.
• Experience in a clinically related subject.
• SAS programming skills required, R programming skills a plus.
• Good leadership skills with the ability to work confidently and independently in a matrix team.
• Strong oral and written English communication skills.

High-quality statistical deliverables across global Phase I-IV clinical trials depend on the Senior Biostatistician, who specifies, produces, and quality controls analysis and reporting outputs including statistical analysis plans and integrated summaries of efficacy and safety. Based within a pharmaceutical, CRO, or academic institution setting, this role serves as Lead Biostatistician with full responsibility for planning and coordinating all statistical activities on allocated studies.

Accountabilities

• Provide expert statistical input to Phase I-IV global clinical trials including the design of clinical trials and production of analysis and reporting deliverables.
• Specify, produce and quality control analysis and reporting deliverables including statistical analysis plans and integrated summaries of efficacy and safety.
• Perform statistical programming and quality control of analysis datasets containing statistical elements, tables and figures for global phase I-IV trials.
• Ensure the quality and timeliness of statistical deliverables.
• Act as Lead Biostatistician with primary responsibility for all statistical activities on allocated studies including planning and coordination for assigned team members.

Professional Experience

• MSc in Medical Statistics or a degree in Statistics/Mathematics with demonstrable experience as an applied Statistician at a pharmaceutical company, CRO or academic institution.
• Strong experience of project managing statistical activities as Lead Biostatistician, including timelines, forecasting and budgets.
• Expert knowledge of clinical trial practices, procedures and methodologies and the statistical principles underlying them.
• Experience providing statistical input into study protocols, sample size calculations and Bayesian adaptive designs.
• Good SAS programming abilities with strong oral and written communication skills.
• Ability to work independently as well as collaboratively with colleagues.

As the Senior Biostatistician, this role develops and analyzes a variety of research data using statistical methods, including creating and maintaining biostatistical documentation and reviewing statistical analysis plans, SAS programs, and reports across women's health and HIV research. The Infectious Diseases Division relies on this work to deliver sound statistical methods sections, accurate study reports, and mentorship that strengthens the broader biostatistical team.

Strategic Responsibilities

• Develop and analyze a variety of research data using statistical methods.
• Keep abreast of the latest statistical modeling and computing tools.
• Prepare statistical method sections for inclusion in study protocols.
• Develop and validate statistical programs to support statistical analyses.
• Provide interpretations of statistical results and prepare relevant statistical sections for study reports.
• Create and maintain biostatistical documentation including descriptions of methods, SAS programs and results.
• Review and audit statistical analysis plans, SAS programs and statistical reports including tables, listings and figures.
• Guide more junior biostatisticians and serve as a resource to biostatisticians, programmers and data analysts.

Education and Experience

• MS in Biostatistics with experience performing collaborative biostatistics in an academic setting, especially in women's health and/or HIV.
• 3 years of experience as a biostatistician, preferably in an academic setting.
• Experience analyzing longitudinal data from a variety of studies, including small pilot and large multi-site studies.
• Experience working with complex projects involving multisite designs and large numbers and variety of data sources.
• SAS proficiency required, with proficiency in other statistical programs such as R and REDCap desirable.
• Strong organizational and time management skills with ability to manage multiple projects simultaneously.

Senior Biostatistician delivers statistical leadership across multiple complex NDA protocols by reviewing sample size calculations, writing analysis plans, and preparing Integrated Summaries of Safety and Efficacy for sponsor and regulatory agency audiences. Success in the position means leading programmers and data management personnel, mentoring junior statisticians, and ensuring project management rigor across concurrent high-stakes deliverables.

Ownership Areas

• Work independently as a project lead or lead statistician to deliver on tasks across challenging projects and lead team members across multiple complex projects.
• Review sample size calculations and protocols for completeness, appropriateness of clinical design and sound statistical analysis.
• Write and review analysis plans and guide team members in their implementation.
• Define appropriate methods and procedures for statistical analysis and review statistical analysis for key efficacy endpoints.
• Review specifications for analysis database, oversee its development and assure completeness for use in all programming.
• Oversee collaboration with programmers and data management personnel on database maintenance, updating and documentation.
• Supervise creation of table and listing specifications.
• Prepare reports, manuscripts and other documents including statistical methods sections for Integrated Clinical and Statistical Reports and Integrated Summaries of Safety and Efficacy.
• Mentor others in the application of more complex statistical methodologies.

Background and Experience

• Master's degree in Statistics, Biostatistics, Mathematics or related field with 4+ years of relevant experience.
• Comprehensive understanding of a wide variety of clinical trials, designs and corresponding reporting of data.
• Strong project management skills demonstrated through management of multiple projects.
• Comprehensive SAS programming skills, proficient in BASE, STAT, MACRO and GRAPH.
• Capable of directing and promoting teamwork in a multi-disciplinary team setting.
• Excellent written and verbal communications skills, including proficiency in English.

The Senior Biostatistician produces statistical analyses and develops new analytic methods in support of psychiatric research on PTSD, alcohol abuse, and opioid disorders, including application of random forests, neural nets, and growth curve modeling to clinical and psychophysiological data. Collaborating with the Department of Psychiatry Biostatistics Group at New York University School of Medicine, this role advances both applied research outcomes and publishable methodological contributions.

Key Deliverables

• Work with Psychiatry Department members to utilize relevant data to answer research questions by providing data summaries, preliminary analyses and figures.
• Contribute to research design, data collection methods and conduct power analyses and data analytic sections of research publications and grant applications.
• Conduct statistical analyses for research manuscripts for publication.
• Report and assist in the interpretation of results of analyses.
• Work with members of the Biostatistics group in the development of new statistical methods and their application in psychiatric research.
• Work with members of the Biostatistics group to write publishable journal articles on new analytic work.
• Generate publication quality figures for presentations and journals.

Minimum Qualifications

• PhD in Statistics with training or experience in clinical trial design, machine learning and epidemiology.
• 3 years of experience post graduation with graduate experience in psychological and psychophysiological research.
• Experience in the application of random forests, neural nets and growth curve modeling.
• Familiarity with processing and analysis of biological signals such as EKG, blood pressure and skin conductance, and with psychophysiological data acquisition equipment.
• Familiarity with specialized techniques of data analysis for psychophysiological data, including time series analysis.
• Strong interpersonal, written, oral communication and organizational skills with ability to manage multiple projects under minimal supervision.

Embedded within a growing biostatistics and data science team, the Senior Biostatistician develops statistical methods sections of study protocols and statistical analysis plans, executing interim and final analyses across clinical trials and real-world studies. Working closely with internal and external stakeholders, this role advances product development projects by integrating machine learning and data science to improve clinical care outcomes.

Role Responsibilities

• Represent the biostatistics and data science function and collaborate with internal and external stakeholders in the design, analysis, interpretation and publication of clinical studies and trials.
• Direct the biostatistical activities on a study as biostatistical lead and be accountable for the relevant deliverables.
• Develop statistical methods sections of study protocols and statistical analysis plans.
• Perform sample size and power calculations, execute interim and final statistical analyses, communicate findings to stakeholders and prepare written reports.
• Stay current with the latest methodological advances in real world studies.
• Leverage partners where necessary to accomplish projects where internal team capacity may not be adequate.
• Participate in assigned new product development projects leveraging machine learning and data science to improve clinical care.

Qualifications and Experience

• PhD or Masters in Biostatistics, Statistics or Epidemiology with 2+ years (PhD) or 4+ years (MS/MA) of relevant experience.
• Thorough understanding of clinical trial methodology and statistical methods including methods for time-to-event analysis.
• Extensive knowledge and experience in meeting FDA regulatory guidelines with hands-on experience preparing regulatory submissions.
• Familiarity with machine learning techniques and their advantages and disadvantages, especially for predictive and prognostic algorithms in medical research.
• Computational skills using Python, R or SAS, especially relevant statistical tools and packages.
• Collaborative mindset with excellent verbal and written communication skills and proven ability to work with geographically distributed teams.

Reporting to Westat research leadership, the Senior Biostatistician oversees all phases of GWAS and related omics data analyses, establishing data pipelines, harmonizing data across studies, and producing summaries for peer-reviewed manuscripts and regulatory audiences. Partnering with external investigators and internal project teams, this role refines analytical approaches for transcriptome-wide, methylation-wide, and gene-environment interaction analyses using FAIR guiding principles.

Day-to-Day Responsibilities

• Collaborate with the research team to develop data analysis plans.
• Advise the research team on the appropriateness and feasibility of analytic tools and techniques specific to GWAS and related ""omics"" analyses.
• Oversee, lead and consult on all phases of the analysis process using FAIR guiding principles to establish data pipelines, manage, merge and harmonize data across sources and studies.
• Prepare analytic datasets, carry out analytical programming and implement quality control measures throughout.
• Prepare documentation and provide summaries of study findings in manuscripts, tables and through data visualization tools.
• Present results orally and in writing to internal and external audiences, incorporating descriptions of methods and relevant literature to provide context.

Technical Qualifications

• PhD in Biostatistics, Statistics, Bioinformatics, Epidemiology or a related field.
• 5 years of advanced biomedical ""omics"" data analysis experience.
• Experience with SAS, R, Python and other statistical packages and tools specific to ""omics"" analyses.
• Ability to assess existing tools and identify novel tools and approaches for ""omics"" analyses.
• Expert ability to identify and resolve analytic issues using knowledge, problem solving and troubleshooting skills.
• Ability to express complex statistical concepts and technical information clearly to audiences with and without formal statistical training.

Sitting at the intersection of statistical science and sponsor communication, the Senior Biostatistician develops statistical analysis plans and oversees SAS programming to create datasets, TLGs, and case report form reviews that directly support the drug development process. Operating across a global CRO environment, this role serves as lead biostatistician and bridges sponsor teams and internal study staff to advance project deliverables on time.

Work Activities

• Provide statistical consulting as lead biostatistician and communicate between sponsor and study team.
• Prepare datasets and develop statistical analysis plans.
• Review study documents including data management plans and case report forms.
• Develop and oversee SAS programs to create datasets and listings, tables and graphs.
• Support team leads and senior reviewers to meet project deliverables.

Knowledge Skills and Abilities

• Advanced degree (MS or PhD) in Statistics or closely related field.
• 4+ years of biostatistics experience within CROs.
• 2+ years of lead experience and IVD experience is a plus.
• Demonstrated experience of SAS macro development, code generation and algorithms.
• Working knowledge of CDISC standards and applying those standards to projects.

A key member of a cross-functional R and D team, the Senior Biostatistician develops statistical input for In Vitro Diagnostic study designs, validation activities, and manufacturing quality control programs spanning IVD assay development, systems integration, and process development. Collaborating across bioinformatics, regulatory, and manufacturing functions, this role builds process control procedures and novel statistical methodologies that ensure product integrity and regulatory compliance.

Technical Responsibilities

• Provide statistical input to study designs to support In Vitro Diagnostic development and verification studies, and reagents manufacturing/quality control development/validation studies.
• Ensure statistical integrity is applied to development and validation activities.
• Provide statistical sampling plans for quality control of various manufactured products.
• Develop process control analysis and procedures to ensure control of manufactured products.
• Provide statistical support as part of Change Control for products and manufacturing processes.
• Contribute statistical expertise and guidance to others in the organization.
• Work collaboratively in cross-functional teams on new product design development and validation.
• Propose new and novel statistical methodological approaches and clearly communicate statistical concepts, rationale and study results to cross-functional teams.

Position Requirements

• PhD preferred but MS or equivalent in Statistics, Mathematics, Computational Methods or related discipline, with additional training in biochemistry or molecular biology highly desired.
• 3+ years of demonstrated success in the life sciences field with increasing responsibility and independent thinking.
• Expert in non-clinical biostatistics, with experience in clinical biostatistics a plus.
• Familiarity with regulatory requirements for IVD products, ISO 13485, 21CFR820, IVDR and applicable experience in medical device or biotech manufacturing.
• Experience using diverse and fit-for-purpose experimental design techniques with expert knowledge of various statistical software packages.
• Highly organized with strong interpersonal skills and excellent oral and written communication skills.

Delivering rigorous statistical support for Phase I-IV clinical trials depends on the Senior Biostatistician, who formalizes analysis plans, conducts biomarker analyses, supports safety reporting, and contributes to scientific manuscripts and regulatory dossiers across endocrine, metabolic, and rare disease programs. Based within a pharmaceutical or biotech clinical development team and collaborating with regulatory agencies and IRBs, this role serves as the subject-matter expert for statistical strategy, scenario simulations, and CRO oversight.

Strategic Initiatives

• Participate in the design of clinical protocols and analysis and reporting of clinical trial data.
• Provide critical input in optimizing trial designs and support scenario simulations and sample size calculations based on relevant technical and disease area knowledge.
• Assist in the preparation of clinical trial documents, reports, investigator brochures, other regulatory reporting documents and responses to requests from regulatory agencies and IRBs.
• Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Work with team to formalize analysis plans and reporting specifications and advise on statistical analysis strategies, reliability of measurements and interpretation of statistical results.
• Contribute to the preparation of scientific abstracts and manuscripts.
• Build and sustain collaborative relationships with individuals in different disciplines and serve as subject-matter expert for the team and collaborators.
• Support statistical aspects of business-critical and/or regulatory commitments and provide oversight of CROs in conjunction with the rest of the clinical team.

Skills and Qualifications

• Master's degree or PhD in Statistics or related field with 8+ years of relevant pharmaceutical/biotech experience.
• Experience in endocrine/metabolic or rare disease clinical trials preferable.
• Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials, including experience representing the Statistics function with regulatory agencies.
• Knowledge of data management principles, regulatory requirements for clinical trials and the clinical drug development process.
• Ability to apply a range of advanced statistical techniques, program and manage complex statistical computer databases and conduct scenario simulations.
• Proficiency in SAS programming and/or other statistical software with expertise in statistical programming, modeling and simulations.
• Strong analytical communication, critical thinking and problem-solving skills with ability to provide technical guidance to the team.

As the Senior Biostatistician, this role refines analytic plan design, manages data extracted from SQL databases, executes advanced HEOR analyses, and supports dissemination of health outcomes research through peer-reviewed publications. The Intervention Science team relies on this work to differentiate the organization as a leader in digital therapeutics and to advance behavioral health research across internal and external stakeholder groups.

Scope of Work

• Leverage deep statistical expertise to align with company objectives and timelines.
• Complete analytic plan design, data management, analysis, reporting and quality control of research results and statistical information, including by extracting data from SQL databases and documenting code and applicable datasets.
• Facilitate the success of product research at various stages, from stakeholder alignment on aims to developing an analytic plan, executing analyses and supporting results dissemination via peer-reviewed publications.
• Build and bolster strong, effective and collaborative interpersonal relationships with stakeholders.
• Actively contribute to scientific writing toward disseminating health outcomes research to both internal and external stakeholders.

Experience and Qualifications

• PhD or MS in Statistics or Biostatistics, or PhD in Psychology, Public Health or Sociology with extraordinary methodological and analytic capabilities.
• 3-8+ years of health outcomes research focused on behavioral health, digital and/or life sciences.
• Experience with advanced statistical techniques including cluster, latent and survival analyses, Bayesian and nonparametric statistics and power/sample size calculations.
• Expertise with HEOR analyses such as causal inference, propensity score matching, trajectory-based and sensitivity analyses, and knowledge of large database analyses and cost-related analyses such as decision trees, Markov models and microsimulation.
• Experience analyzing clinical trial data, psychometric testing and statistical expertise for digital therapeutics, medical devices and SaMD.
• Proficiency with SAS, R, Python, SPSS and SQL, with experience writing code for reproducible research and version control using GitHub.
• Ability to communicate research process and results in writing, visualizations and presentations to both scientific and lay audiences.
• A record of peer-reviewed publications demonstrating scientific acumen.

Senior Biostatistician develops statistical analysis datasets, prepares documentation, and drives quality control of analysis data and TLGs in support of clinical and observational studies for medical device and CRO clients. The work directly supports regulatory compliance, proposal development, and prospective client engagements by ensuring schedule, budget, and quality commitments are met across all assigned projects.

Executive Functions

• Prepare datasets for analysis by merging files, creating analysis variables, editing data and developing documentation.
• Interpret results of analysis for a wide variety of audiences.
• Contribute to the design and use of appropriate data collection and quality control methods.
• Promote good statistical practice for the support of sound scientific judgments.
• Develop positive relationships with clients as well as with colleagues.
• Ensure schedule, budget and quality commitments are met for the client within the scope of control.
• Communicate project and team issues to project management and handle challenging situations appropriately.
• Contribute to presentations including preparation, assembling slides and speaking.
• Provide scope of project and relevant information to support the creation of proposals.

Background and Experience

• Master's or Doctorate in Biostatistics, Statistics, Epidemiology, Applied Math or similar, with 4+ years of relevant experience, or Bachelor's degree with 8+ years of relevant experience.
• Proficiency in SAS and statistical programming language with expert ability to organize and manipulate large datasets.
• Preferred CRO work experience.
• Ability to express complex statistical concepts and technical information to researchers.
• Exceptional verbal and written communication skills with eagerness to learn and flourish in a collaborative environment.

The Senior Biostatistician creates detailed specifications for study design and analysis plans, executes sample size calculations and statistical analyses, and guides regulatory agency interactions as subject matter expert for IVD and molecular biology products. Collaborating with Quality Assurance, scientists, and engineers across a multidisciplinary product development team, this role elevates statistical rigor in 510(k) and PMA submissions while driving innovation in machine learning and genomics-based methodologies.

Delivery Expectations

• Prepare and write detailed specifications for study design and analysis plans.
• Provide statistical direction for product development, experimental study design and publication strategy.
• Collaborate with Quality Assurance personnel and scientists to design experiments that are scientifically valid and conform to Good Laboratory Practice, set project timelines and product claims.
• Perform sample size calculations, statistical analyses, results interpretation, write statistical summaries and help prepare analytical reports for regulatory agencies to evaluate the performance of new and improved products.
• Interact with regulatory agencies as subject matter expert to support the review process of statistical methodology employed in clinical trials.
• Participate in brainstorming sessions, contributing ideas for developing technology, algorithms and products.
• Stay current with statistical research and use novel methodology as appropriate.
• Prepare and deliver presentations highlighting progress and achievements.

Knowledge Skills and Abilities

• PhD with 2+ years of experience, Master's in Biostatistics or equivalent with 5+ years of experience, or Bachelor's with 7+ years of experience within a medical device environment.
• Knowledge of FDA regulations pertaining to IVDs with a successful track record for 510(k) and PMA submissions, and intimate understanding of CLSI and other standards applicable to IVD design, development and clinical validation.
• Well versed in standard statistical analysis methods such as Wilsons, Bootstrap and ANOVA, with basic understanding of molecular biology.
• Previous experience with data modeling and statistical methods such as linear modeling or machine learning/deep learning preferred, with familiarity in genomics data a plus.
• Proficient in SAS, R, Python, Minitab, JMP, Stata, SPSS or other high-level statistical packages.
• Strong ability to present technical information to a non-technical audience in a multidisciplinary, fast-paced environment.

Embedded within an Institute research environment, the Senior Biostatistician serves as statistical co-lead on studies and develops novel algorithms to analyze single-cell omics data, including power analysis, sample size calculations, and integrative multi-modal data analysis. Working closely with experimentalists, bioinformaticians, and outside collaborators, this role coordinates cross-functional meetings and contributes to reports, patents, and research papers advancing immunology and high-throughput technology programs.

Areas of Ownership

• Serve as statistical co-lead on Institute studies and projects and analyze diverse clinical, immunologic and molecular data.
• Develop novel algorithms to analyze single-cell omics data.
• Develop and execute statistical analysis plans for clinical studies, including power analysis and sample size calculations.
• Provide support to experimentalists and bioinformaticians on experiment design, data analysis and statistical inference.
• Participate in cross-functional collaborations and meetings as lead statistics expert.
• Write or contribute to reports, research papers, patents and other documents.
• Update bioinformatics team of new statistical methods related to ongoing research.

Professional Experience

• PhD degree or equivalent combination of degree and experience with 5-10+ years of post-PhD experience or 3+ years of relevant post-MS experience.
• 10+ years of hands-on experience analyzing high-throughput omics data, developing statistical analysis plans and designing clinical studies and/or complex multi-assay experiments.
• Track record of developing new algorithms for analyzing omics data with deep understanding of methodologies underlying popular tools in the field.
• Experience in integrative analysis of multiple data modalities, data visualization, dimensionality reduction and single-cell technologies.
• Experience in molecular biology, high-throughput technologies and immunology, with experience working with outside collaborators.
• Fluency in R or other statistical computing languages, with working knowledge of Linux, shell scripting, cloud computing and version control systems such as Git.
• Excellent written and verbal communication skills and organizational skills.

Reporting to a senior team member, the Senior Biostatistician develops statistical analysis plans, programs and validates statistical tables, and guides clinical data management personnel on database design and critical data across CRO, pharma, and biotech study environments. Partnering with Statistical Programmers, Clinical Data Managers, Regulatory Affairs, and Clinical Pharmacology staff, this role coordinates multi-functional deliverables to meet timelines for statistical data analysis and reporting.

Job Functions

• Interact with the sponsor on all aspects of the project with oversight from a senior team member.
• Coordinate with programmers and data management personnel on database maintenance, updating and documentation, and provide guidance for database structures for analysis.
• Develop statistical analysis plans including table and listing specifications and guide team members in their implementation.
• Program and validate statistical tables with an emphasis on efficacy endpoints, provide proper documentation and oversee the work of others who assist in programming.
• Perform protocol development, sample size calculation, protocol and CRF review and advise data management on database design and critical data.
• Provide data analysis and presentation methods to support clinical studies, publications and presentations.
• Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Data Managers and other Clinical, Regulatory and Project Management staff to produce project deliverables and meet timelines.

Education and Experience

• MS in Statistics, Mathematics or a closely related field, with PhD in Biostatistics or equivalent preferred.
• 1+ year of experience in CRO, Pharma or Biotech.
• Understanding of GCP, ICH and FDA guidelines and regulations applicable to clinical research.
• Experience with statistical methods commonly used in the analysis of clinical trial data.
• Experience with SAS Base and SAS Stat with strong data step skills, and experience with other statistical software such as N-Query and S-Plus.
• Ability to synthesize results in graphic, oral and written reports.

Sitting at the intersection of clinical pharmacology and regulatory science, the Senior Biostatistician provides statistical input into study protocols, DSMBs, and regulatory submission dossiers, including managing integrated PK analyses and leading electronic submissions of clinical data to authorities. Operating across pharma and biotech clinical trial operations, this role coordinates biostatisticians and statistical programmers as Lead Biostatistician while generating innovative statistical methodologies appropriate to each project.

Leadership Responsibilities

• Provide statistical input into study protocols, Case Report Forms and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications and perform statistical analyses.
• Provide statistical output as required for manuscripts and ensure that results are accurately interpreted in publications.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities and participate in meetings with regulatory authorities.
• Manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes when acting as Lead Biostatistician.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies appropriate to each project.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Required Qualifications

• Master's degree in Statistics, Biostatistics or related discipline with 5-10 years of experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry.
• Experience in eSUB, contributing to and reviewing the summary of clinical pharmacology, integrated PK analyses and clinical pharmacology required.
• Knowledge of relevant international regulatory guidelines applicable to clinical development and experience of regulatory interactions and data submission to FDA.
• Demonstrated team leadership for both direct and indirect reporting relationships.
• Working SAS and CDISC knowledge required, with knowledge of PK/PD desired.
• Experience in immunology, dermatology or gastroenterology a plus.

A key member of a clinical biostatistics team, the Senior Biostatistician provides statistical support to clinical studies across various therapeutic areas, developing statistical analysis plans with TLG specifications and preparing integrated summaries for regulatory submissions. Collaborating with clinicians and statistical programmers, this role executes analyses using CDISC SDTM and ADaM data standards and SAS programming while leading study activities when called upon.

Core Responsibilities

• Provide statistical support to clinical studies with a focus on various therapeutic areas.
• Participate in the development of study protocols, including study design discussions and sample size calculations.
• Review CRFs and data review guidelines and develop statistical analysis plans including analysis dataset and TLG specifications.
• Perform statistical analyses, interpret statistical results and prepare clinical study reports including integrated summaries for submissions.
• Lead study activities when called upon and serve as a team player to meet deadlines and adapt when priorities change.

Qualifications and Experience

• MS or PhD in a statistical field with 4+ years of relevant clinical trial biostatistics support in design, analysis and interpretation.
• Proven experience working with clinical trial data in support of safety and efficacy analysis.
• Capacity to interface effectively with clinicians and statistical programmers and to work independently or under the guidance of a more senior statistician.
• Knowledge and practice of CDISC SDTM and ADaM data standards.
• Knowledge of SAS programming including SAS/STAT, SAS/BASE and SAS macro language.

Delivering statistically sound clinical development programs depends on the Senior Biostatistician, who plans, performs, and documents statistical analyses in accordance with study protocols and regulatory requirements across assigned Study Teams within the Global Biometrics Department. Serving as a point of contact for health and regulatory authorities and coordinating ADaM mapping with senior programmers, this role manages clinical data security and produces statistical reports that underpin submission-ready evidence.

Operational Focus

• Plan, perform, report and document statistical tasks during the study process.
• Assist in the development of Study Protocols, CRFs and reports/manuscripts by providing statistical input.
• Contact health/regulatory authorities regarding statistical issues when needed.
• Plan and perform statistical analysis, interim and/or final, in accordance with the Study Protocol and the statistical analysis plan.
• Coordinate ADaM mapping with the senior programmer when needed, and document and validate programs and files for analysis.
• Manage clinical data to ensure security and confidentiality.
• Produce and review statistical reports.

Requirements

• BSc or Master's in Biostatistics, Statistics
• 5+ years of relevant statistical experience in pharmaceutical or CRO industry.
• Experience with the use of statistical methodology applied to clinical trials.
• Proficiency in SAS programming.
• Ability to deal effectively with sponsors and internal customers.
• Excellent verbal and communication skills with ability and willingness to travel on occasion.

As the Senior Biostatistician, this role guides multidisciplinary subject matter experts through the collection, analysis, and interpretation of clinical trial data, including defining randomization, programming statistical analyses in SAS, and writing and archiving all statistical documents such as analysis plans and scientific publications. The clinical research team relies on this work to maintain project timelines and deliver validated, submission-ready statistical reporting across phases of clinical development.

Key Responsibilities

• Participate in preparation of study protocol including sample size calculation.
• Define randomization of clinical trials.
• Program statistical analysis in SAS software in accordance with the study protocol.
• Write, validate and archive all statistical documents such as analysis plans, study reports, presentations and scientific publications.
• Oversee project timelines and deliverables, review analysis results and reports and document activities and deliveries.

Qualifications and Experience

• Master's or PhD in Applied Mathematics or Statistics with 5+ years of experience in medical statistics/biostatistics, preferably in clinical research.
• Experience in SAS programming and validation/QC of SAS programs to develop descriptive tables, listings and figures.
• Experience in CDISC standards (SDTMs and ADaMs) is an advantage.
• Good organizational and presentation skills with ability to work to deadlines while maintaining quality standards.
• Fluency in English, with knowledge of other languages a plus.