• Provide statistical support to indication(s)/product(s) primarily within Medical Affairs
• Help define future research questions and plan, execute statistical analysis
• Provide input into the Medical Affairs lifecycle management strategy and tactics
• Interpret, explain, and discuss results of complex statistical analyses with both technical and non-technical colleagues
• Be responsible for implementing consistent statistical conduct for the department 
• Liaising with clinical research and medical affairs personnel
• Leader in the development of life-changing treatments for people with uterine fibroids, endometriosis, prostate cancer, and infertility
• Committed to working with scientific integrity in a collaborative, supportive, and respectful manner while embracing the challenge
• Inception, training and validation of predictive models using data.
• Technical supervision and mentoring of Junior Biostatisticians and Data Scientists of the Data Team. 

Skills: Statistical Support, Research Planning, Strategy Input, Results Interpretation, Consistent Conduct, Collaboration, Treatment Development, Integrity

• Lead project team on production and quality control of integrated clinical reports
• Perform QC on TFD produced by other department members
• Act as supporting role as a non-voting independent statistician for DMC review
• Interact with clients as key contact regarding Statistical and Contractual Issues
• Leadership in the planning and execution of statistical analysis of observational studies run using Savana databases. 
• Elaboration of SAP documents for observational studies conducted with Databases.
• Data extraction, data cleansing, data munging and statistical analysis of databases.
• Elaboration and review of technical documents related to statistical analysis and interpretation
• Communication and defense of the results obtained in studies to different audiences (internal and external clients).

Skills: Team Leadership, Quality Control, Statistical Support, Client Interaction, Study Planning, Analysis Planning, Database Management, Results Communication

• Analyzes clinical trial data, validates statistical output
• Act as statistical team lead on various studies
• Approval of the clinical study report and supervise junior statistics staff
• Participates in the CRF development process and provides input on data cleaning issues.
• Interprets accurately, and communicates statistical results and concepts to non-statisticians
• Ensures the high quality of all services and deliverables provided by Statistics at Ergomed
• Collaborates effectively with members of clinical trial teams and with Biometrics colleagues
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance
• Supports Ergomed Clinical and Biometric Project Managers to ensure the timely, accurate and appropriate processing of clinical trial data to support clinical trial reporting
• Supports Ergomed Clinical and Biometric PMs with the use of SAS and assist with tasks such as database reconciliation and validation using SAS programming

Skills: Data Analysis, Team Leadership, Report Supervision, CRF Development, Statistical Communication, Quality Assurance, Collaboration, Continuous Learning

• Provide input on publications and data analysis
• Conduct exploratory analyses to inform design of new clinical trials
• Conduct statistical analyses for data monitoring committees
• Communicate statistical results to medical writing team to ensure accurate interpretation
• Provide input on case report forms and clinical databases to ensure quality data collection
• Provide statistical expertise and conduct ad hoc data analysis for publication/abstract submissions
• Work closely with clinical teams in designing clinical studies and serve as statistical lead on multiple clinical studies
• Collaborate with core stakeholders to provide statistical expertise in support of product development and regulatory submissions
• Develop statistical analysis plans (SAP), conduct statistical analyses, and provide statistical input to clinical study reports (CSRs)
• Program clinical research data for ease of analysis on ongoing basis, particularly for observational, hypothesis generating studies

Skills: Publication Input, Exploratory Analysis, Data Monitoring, Medical Communication, Form Oversight, Ad Hoc Analysis, Study Design, Stakeholder Collaboration

• Lead the development of protocols, analysis plans, publications and other health economic project outputs by working in matrix project teams.
• Lead discussions with clients/partners in the selection of appropriate study design and methodologies in health economic projects.
• Use appropriate techniques and interpret results in the context of study/research questions and to meet client/partner's objectives.
• Deliver projects according to client requirements, on-time and on-budget.
• Be the subject matter expert in health economics and answer queries across Clarivate’s teams.
• Lead (technical) and manage (financial, administrative, client) projects that involve statistical analyses and reporting.
• Provide strategic statistical input into the generation of healthcare evidence 
• Incorporating state-of-the-art statistical methodologies into resolution of client problems.
• Contribute to the statistical planning and design of studies 
• Working with the Team Leader / Specialist Team staff /Project Managers both in projects with a primary statistical deliverable 

Skills: Protocol Development, Study Design Consultation, Results Interpretation, Project Management, Subject Matter Expertise, Project Leadership, Strategic Input, Statistical Planning

• Experience in relevant industry, experience during doctoral-level studies 
• Ability to obtain and maintain a public trust clearance
• Experience with interventional clinical trials
• Experience with diagnostic and device studies
• Experience with animal studies
• Experience in both CRO and pharma preferred
• Strong programming skills in SAS and R
• Ability to work collaboratively with others in a team environment
• Experience gained within Pharmaceutical companies and/or CROs;
• Ability to confidently present and communicate findings, information, issues, outcomes, … both in written and oral forms

Qualifications: BA in Biology with 12 years of Experience 

• Be capable to lead a team of statisticians
• Have the ability to maintain a schedule for projects and goals for milestones
• Strong knowledge of SAS and statistical analysis experience 
• Ability to work independently (sample size calculation, regulatory guidelines, etc.)
• Know statistical methodologies
• Have experience in the medical device or biopharmaceutical industry
• Understand data programming to facilitate statistical analyses
• Experience in designing experiments, sampling plans, and statistical analysis.
• Have cognitive skills and experience working with complex problems where data requires in-depth evaluation.
• Be leadership and influencer with the ability to interface with management on matters of significance.

Qualifications: BS in Biostatistics with 5 years of Experience 

• Excellent communication skills
• Extensive experience within the Pharmaceutical and/or Biotechnology industries
• Experience in statistical support to Medical Affairs, patient-reported outcomes
• Experience in studies using external databases, and real-world studies
• Experience in the late stage of clinical development
• Experience in using meta-analysis and contributing to the content of INDs/NDAs/BLAs
• Demonstrated abilities in providing insight into patterns within data to shed new light on optimal ways in which treatments should be used
• Know Bioinformatics (around DNA / RNA / Proteomics data analysis) and/or Statistical Genetics

Qualifications: BS in Biomedical Engineering with 8 years of Experience 

• Expertise in areas of Computational Biology and Statistical Genetics
• Expertise in areas of Applied Data Science and Large-Scale / ‘Big Data’ Computation
• Expertise in areas of Statistical and Machine / Deep Learning, Analysis of Clinical Trial Datasets (SDTM/ADAM), and/or RWE Data
• Strong experience with Python and R for data analysis
• Experience with computational environments for large-scale data science 
• Be aware of Statistical and Machine or Applied Deep Learning methods for time series data or images
• Have a good understanding of drug development processes and strategies;
• Be motivation, excellent team player, and independent and well-structured way of working
• Know Bioinformatics (around DNA / RNA / Proteomics data analysis) and/or Statistical Genetics
• Be aware of Statistical and Machine or Applied Deep Learning methods for time series data or images

Qualifications: BS in Biomedical Engineering with 7 years of Experience 

• Demonstrated knowledge of and experience in using multiple advanced statistical methods
• Excellent working knowledge of R and familiar with another statistical analysis software 
• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
• Proficiency in SAS statistical programming.
• Knowledge of other statistical and data management software packages is a plus.
• Strong written and oral communication skills.
• Experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
• Ability to program in one or more statistical software packages used to conduct statistical analyses. 
• Proven ability to effectively communicate statistical concepts 
• Good knowledge of the overall clinical trial process and of its application within Labcorp Drug Development

Qualifications: BS in Data Science with 7 years of Experience