Associate Principal Biostatistician Clinical Safety Statistics (CSS)
Merck
June 27, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Key responsibilities for the position
- Provide statistical support and leadership for projects related to the evaluation of clinical safety data.
- Interact with cross-functional Risk Management Safety Teams (RMSTs) to plan and execute evaluations of safety data; serve as a statistical representative and core RMST member.
- Design, develop, and evaluate processes, methods, and tools for safety data evaluation.
Primary activities for the position
- Collaborate with Clinical Safety/Risk Management, Clinical Research, Early/Late Development Statistics, Epidemiology, Scientific Programming, and others on drug/vaccine safety evaluation from IND through NDA to post-marketing.
- Provide statistical support and leadership to RMSTs for safety-evaluation strategic planning and statistical analysis.
- Plan and execute aggregate safety evaluations for clinical trials, regulatory documents (e.g., DSUR, IB), and safety inquiry responses; ensure deliverables meet analysis requirements, SOPs, and regulatory requirements.
- Evaluate software appropriateness for planned analyses; determine need for novel statistical methods or programming.
- Design, develop, and evaluate processes/methodology/tools for ongoing aggregate safety data analysis.
- Prepare and present oral/written reports of safety analysis results to project teams, management, regulators, or investigators.
- Stay current on regulatory guidance and methods for safety data evaluation.
- Participate in research for innovative statistical methods and applications in clinical safety evaluation.
Education and minimum requirements
- PhD (or equivalent) in statistics/biostatistics or related field with 3+ years relevant experience; or Master’s with 6+ years relevant experience.
Required skills and experience
- Solid statistical methods knowledge (survival, meta-analysis, Bayesian).
- Clinical trial design and analysis experience.
- Safety data (integrated) analysis/interpretation.
- SDTM and ADaM dataset specifications/creation/use.
- Proficiency in SAS and/or R (including R-Shiny); ability to generate statistical graphics.
- Team collaboration; strong oral/written communication, organization, and project management.
- Desire to learn; proactive, motivated; attention to detail and execution.
Preferred skills and experience
- Knowledge of safety signal evaluation/regulatory requirements.
- Knowledge of drug development process (Discovery through post-market safety monitoring).
- Interest in novel safety monitoring/evaluation and benefit-risk assessment methods.
- Peer-reviewed publications; understanding of disease biology/drug discovery.
- AI expertise to support writing and programming.
Application instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Ensure application by the posting’s stated deadline.
- Provide statistical support and leadership for projects related to the evaluation of clinical safety data.
- Interact with cross-functional Risk Management Safety Teams (RMSTs) to plan and execute evaluations of safety data; serve as a statistical representative and core RMST member.
- Design, develop, and evaluate processes, methods, and tools for safety data evaluation.
Primary activities for the position
- Collaborate with Clinical Safety/Risk Management, Clinical Research, Early/Late Development Statistics, Epidemiology, Scientific Programming, and others on drug/vaccine safety evaluation from IND through NDA to post-marketing.
- Provide statistical support and leadership to RMSTs for safety-evaluation strategic planning and statistical analysis.
- Plan and execute aggregate safety evaluations for clinical trials, regulatory documents (e.g., DSUR, IB), and safety inquiry responses; ensure deliverables meet analysis requirements, SOPs, and regulatory requirements.
- Evaluate software appropriateness for planned analyses; determine need for novel statistical methods or programming.
- Design, develop, and evaluate processes/methodology/tools for ongoing aggregate safety data analysis.
- Prepare and present oral/written reports of safety analysis results to project teams, management, regulators, or investigators.
- Stay current on regulatory guidance and methods for safety data evaluation.
- Participate in research for innovative statistical methods and applications in clinical safety evaluation.
Education and minimum requirements
- PhD (or equivalent) in statistics/biostatistics or related field with 3+ years relevant experience; or Master’s with 6+ years relevant experience.
Required skills and experience
- Solid statistical methods knowledge (survival, meta-analysis, Bayesian).
- Clinical trial design and analysis experience.
- Safety data (integrated) analysis/interpretation.
- SDTM and ADaM dataset specifications/creation/use.
- Proficiency in SAS and/or R (including R-Shiny); ability to generate statistical graphics.
- Team collaboration; strong oral/written communication, organization, and project management.
- Desire to learn; proactive, motivated; attention to detail and execution.
Preferred skills and experience
- Knowledge of safety signal evaluation/regulatory requirements.
- Knowledge of drug development process (Discovery through post-market safety monitoring).
- Interest in novel safety monitoring/evaluation and benefit-risk assessment methods.
- Peer-reviewed publications; understanding of disease biology/drug discovery.
- AI expertise to support writing and programming.
Application instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Ensure application by the posting’s stated deadline.