Senior Scientist, Biostatistics, Clinical Safety Statistics
Merck
August 29, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support for program-level evaluation of clinical safety data.
- Partner with cross-functional safety teams (Safety Physicians/Scientists, Clinical Trial Physicians/Scientists, Epidemiologists, Regulatory Liaisons, Early/Late Development Statisticians, Statistical Programmers, etc.) to plan and execute ongoing safety evaluations across pre- and post-marketing stages.
- Design, develop, and evaluate processes/tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level.
Primary Activities:
- Support strategic planning and scientific reasoning for safety evaluation.
- Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis.
- Design/develop/apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
- Collaborate with statisticians/programming staff to ensure high-quality deliverables meeting analysis requirements, SOPs, and external regulatory requirements.
- Prepare oral/written reports communicating safety evaluation results.
- Assess need for novel statistical methodology and evaluate software for planned analyses.
- Conduct research on innovative statistical methods for clinical safety evaluation.
Education/Minimum Requirement:
- PhD (or equivalent) in statistics/biostatistics or related field; or Master’s degree with at least 3 years of relevant experience.
Required Skills/Experience:
- Study design and statistical analysis, especially survival analysis, meta-analysis, Bayesian methods.
- SAS and R (R-Shiny a plus) for statistical/data processing.
- Strong oral/written communication; effective collaboration across functions.
- Initiative, motivation, attention to detail, high-quality execution, and ability to manage multiple priorities.
Preferred Skills/Experience:
- CDISC familiarity (SDTM, ADaM).
- Observational epidemiology methods and confounding control (matching, propensity scores).
- Proficiency using AI tools for writing and analytics.
- Knowledge of regulatory requirements for safety signal detection/evaluation/reporting.
- Understanding of drug discovery/development and disease biology.
- Interest in statistical research in safety monitoring/evaluation and benefit-risk assessment (publications a plus).
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Provide statistical support for program-level evaluation of clinical safety data.
- Partner with cross-functional safety teams (Safety Physicians/Scientists, Clinical Trial Physicians/Scientists, Epidemiologists, Regulatory Liaisons, Early/Late Development Statisticians, Statistical Programmers, etc.) to plan and execute ongoing safety evaluations across pre- and post-marketing stages.
- Design, develop, and evaluate processes/tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level.
Primary Activities:
- Support strategic planning and scientific reasoning for safety evaluation.
- Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis.
- Design/develop/apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
- Collaborate with statisticians/programming staff to ensure high-quality deliverables meeting analysis requirements, SOPs, and external regulatory requirements.
- Prepare oral/written reports communicating safety evaluation results.
- Assess need for novel statistical methodology and evaluate software for planned analyses.
- Conduct research on innovative statistical methods for clinical safety evaluation.
Education/Minimum Requirement:
- PhD (or equivalent) in statistics/biostatistics or related field; or Master’s degree with at least 3 years of relevant experience.
Required Skills/Experience:
- Study design and statistical analysis, especially survival analysis, meta-analysis, Bayesian methods.
- SAS and R (R-Shiny a plus) for statistical/data processing.
- Strong oral/written communication; effective collaboration across functions.
- Initiative, motivation, attention to detail, high-quality execution, and ability to manage multiple priorities.
Preferred Skills/Experience:
- CDISC familiarity (SDTM, ADaM).
- Observational epidemiology methods and confounding control (matching, propensity scores).
- Proficiency using AI tools for writing and analytics.
- Knowledge of regulatory requirements for safety signal detection/evaluation/reporting.
- Understanding of drug discovery/development and disease biology.
- Interest in statistical research in safety monitoring/evaluation and benefit-risk assessment (publications a plus).
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.