Principal Scientist, Biostatistics, Late-Stage Clinical Development
Merck
August 29, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Serve as a statistical lead in project teams.
- Develop, coordinate, and provide biostatistical leadership and support for Late Development drug/vaccine projects.
- Design and analyze clinical trials; coordinate statistical activities with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratories scientists.
- May interact with AROs, CROs, and external statistical consultants.
- May initially focus on a specific disease area (e.g., oncology).
Primary Activities:
- Lead cross-functional strategic planning and execution for product development.
- Support clinical development planning to align study designs with program objectives and worldwide regulatory/marketing needs.
- Independently identify and resolve technical issues in trial design, conduct, and analysis.
- Develop protocols and data analysis plans; determine statistical methodology.
- Participate in database design to ensure data quality and analysis readiness.
- May lead statisticians/programming staff to meet analysis requirements and SOPs, and external regulatory requirements.
- Evaluate software suitability and determine needs for novel methodology/program development.
- Analyze/interprete clinical trial data using basic and complex statistical techniques.
- Prepare oral/written reports for project teams, management, regulators, and investigators.
- Respond to queries on study design, analysis, and interpretation.
- Ensure accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participate in regulatory/scientific discussions; may represent biostatistics at advisory committee meetings.
- Conduct innovative statistical methods research and mentor junior staff.
Education/Minimum Requirements:
- PhD (or equivalent) in statistics/biostatistics or related field + 6 years relevant experience; or Master’s + 9 years.
Required Skills:
- Statistical analysis methods and experimental design.
- Project management.
- Statistical/data processing software (e.g., SAS and/or R).
- Worldwide regulatory knowledge; clinical trial expertise (Phase II–V).
- Strong oral/written communication; effective teamwork.
- Interest in statistical research and novel method application; proactive, motivated, detail-focused execution.
Preferred Skills:
- Peer-reviewed statistical/medical publications.
- Understanding of biology of disease and drug discovery/development.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
- Serve as a statistical lead in project teams.
- Develop, coordinate, and provide biostatistical leadership and support for Late Development drug/vaccine projects.
- Design and analyze clinical trials; coordinate statistical activities with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratories scientists.
- May interact with AROs, CROs, and external statistical consultants.
- May initially focus on a specific disease area (e.g., oncology).
Primary Activities:
- Lead cross-functional strategic planning and execution for product development.
- Support clinical development planning to align study designs with program objectives and worldwide regulatory/marketing needs.
- Independently identify and resolve technical issues in trial design, conduct, and analysis.
- Develop protocols and data analysis plans; determine statistical methodology.
- Participate in database design to ensure data quality and analysis readiness.
- May lead statisticians/programming staff to meet analysis requirements and SOPs, and external regulatory requirements.
- Evaluate software suitability and determine needs for novel methodology/program development.
- Analyze/interprete clinical trial data using basic and complex statistical techniques.
- Prepare oral/written reports for project teams, management, regulators, and investigators.
- Respond to queries on study design, analysis, and interpretation.
- Ensure accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participate in regulatory/scientific discussions; may represent biostatistics at advisory committee meetings.
- Conduct innovative statistical methods research and mentor junior staff.
Education/Minimum Requirements:
- PhD (or equivalent) in statistics/biostatistics or related field + 6 years relevant experience; or Master’s + 9 years.
Required Skills:
- Statistical analysis methods and experimental design.
- Project management.
- Statistical/data processing software (e.g., SAS and/or R).
- Worldwide regulatory knowledge; clinical trial expertise (Phase II–V).
- Strong oral/written communication; effective teamwork.
- Interest in statistical research and novel method application; proactive, motivated, detail-focused execution.
Preferred Skills:
- Peer-reviewed statistical/medical publications.
- Understanding of biology of disease and drug discovery/development.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).