Senior Scientist, Biostatistics, Clinical Safety Statistics
Merck
August 29, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Provide statistical support for program-level evaluation of clinical safety data.
- Collaborate with cross-functional safety teams to plan and execute ongoing safety evaluations across pre- and post-marketing development 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 evaluations.
- Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety.
- Design and apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
- Collaborate with statisticians and statistical programming staff to deliver high-quality outputs meeting analysis requirements and regulatory expectations.
- Prepare oral/written reports communicating safety evaluation results.
- Assess need for novel statistical methodology and suitability of software.
- 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 plus 3+ years relevant experience.
Required Skills:
- Study design and statistical analysis knowledge (survival analysis, meta-analysis, Bayesian).
- SAS and R (R-Shiny a plus) for statistical/data processing.
- Strong oral/written communication and cross-functional collaboration.
- Initiative, attention to detail, high-quality execution, and ability to manage multiple priorities.
Preferred Skills:
- CDISC (SDTM, ADaM), observational epidemiology methods (confounding control), AI tools for writing/programming, regulatory knowledge for safety signal detection/evaluation/reporting, drug discovery/development and disease biology; interest in publication/research.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
- Provide statistical support for program-level evaluation of clinical safety data.
- Collaborate with cross-functional safety teams to plan and execute ongoing safety evaluations across pre- and post-marketing development 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 evaluations.
- Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety.
- Design and apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
- Collaborate with statisticians and statistical programming staff to deliver high-quality outputs meeting analysis requirements and regulatory expectations.
- Prepare oral/written reports communicating safety evaluation results.
- Assess need for novel statistical methodology and suitability of software.
- 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 plus 3+ years relevant experience.
Required Skills:
- Study design and statistical analysis knowledge (survival analysis, meta-analysis, Bayesian).
- SAS and R (R-Shiny a plus) for statistical/data processing.
- Strong oral/written communication and cross-functional collaboration.
- Initiative, attention to detail, high-quality execution, and ability to manage multiple priorities.
Preferred Skills:
- CDISC (SDTM, ADaM), observational epidemiology methods (confounding control), AI tools for writing/programming, regulatory knowledge for safety signal detection/evaluation/reporting, drug discovery/development and disease biology; interest in publication/research.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).