Principal Scientist, Biostatistics, Late-Stage Clinical Development
Merck
August 29, 2026
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Serve as a statistical lead in project teams.
- Develop, coordinate, and provide biostatistical leadership for drug/vaccine projects in Late Development Statistics.
- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and internal research scientists to design and analyze clinical trials and coordinate statistical activities.
- May interact with AROs, CROs, and external statistical consultants.
- Initially may work in a specific disease area (e.g., oncology).
Primary Activities:
- Lead strategic planning and execution for product development as a statistical representative.
- Support clinical development planning to align study designs with program objectives and worldwide regulatory/marketing needs.
- Identify/anticipate technical issues in trial design, conduct, and analysis; propose and execute solutions.
- Develop protocols and data analysis plans; determine appropriate statistical methodology.
- Participate in database design meetings to ensure data quality and analysis requirements.
- May lead statisticians and statistical programming staff to meet analysis requirements, SOPs, and regulatory requirements.
- Evaluate software for planned analyses; identify needs for novel methodology/program development.
- Analyze and interpret clinical trial data; apply basic and advanced statistical techniques.
- Prepare oral/written reports and respond to queries on design/analysis/interpretation.
- May represent biostatistics in regulatory interactions (e.g., advisory committee presentations) and ensure accuracy of Statistical Review Aids.
- Participate in innovative statistical methods research and mentor junior staff.
Education/Minimum Requirement:
- PhD (or equivalent) in statistics/biostatistics (6+ years relevant experience) or Master’s (9+ years relevant experience).
Required Skills/Experience:
- Solid knowledge of statistical analysis and experimental design.
- Strong project management.
- Proficiency with statistical/data processing software (e.g., SAS and/or R).
- Knowledge of worldwide regulatory requirements and clinical trial expertise (Phase II–V).
- Strong oral/written communication and effective teamwork.
- Interest in statistical research and novel methods for clinical trial development; proactive, detail-focused execution.
Preferred Skills/Experience:
- Publications in peer-reviewed statistical/medical journals.
- Understanding of biology of disease and drug discovery/development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.
- Serve as a statistical lead in project teams.
- Develop, coordinate, and provide biostatistical leadership for drug/vaccine projects in Late Development Statistics.
- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and internal research scientists to design and analyze clinical trials and coordinate statistical activities.
- May interact with AROs, CROs, and external statistical consultants.
- Initially may work in a specific disease area (e.g., oncology).
Primary Activities:
- Lead strategic planning and execution for product development as a statistical representative.
- Support clinical development planning to align study designs with program objectives and worldwide regulatory/marketing needs.
- Identify/anticipate technical issues in trial design, conduct, and analysis; propose and execute solutions.
- Develop protocols and data analysis plans; determine appropriate statistical methodology.
- Participate in database design meetings to ensure data quality and analysis requirements.
- May lead statisticians and statistical programming staff to meet analysis requirements, SOPs, and regulatory requirements.
- Evaluate software for planned analyses; identify needs for novel methodology/program development.
- Analyze and interpret clinical trial data; apply basic and advanced statistical techniques.
- Prepare oral/written reports and respond to queries on design/analysis/interpretation.
- May represent biostatistics in regulatory interactions (e.g., advisory committee presentations) and ensure accuracy of Statistical Review Aids.
- Participate in innovative statistical methods research and mentor junior staff.
Education/Minimum Requirement:
- PhD (or equivalent) in statistics/biostatistics (6+ years relevant experience) or Master’s (9+ years relevant experience).
Required Skills/Experience:
- Solid knowledge of statistical analysis and experimental design.
- Strong project management.
- Proficiency with statistical/data processing software (e.g., SAS and/or R).
- Knowledge of worldwide regulatory requirements and clinical trial expertise (Phase II–V).
- Strong oral/written communication and effective teamwork.
- Interest in statistical research and novel methods for clinical trial development; proactive, detail-focused execution.
Preferred Skills/Experience:
- Publications in peer-reviewed statistical/medical journals.
- Understanding of biology of disease and drug discovery/development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.