Principal Scientist, Biostatistics
Merck
August 22, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Principal Scientist, Biostatistics
Responsibilities
- Develop, coordinate, and provide biostatistical support for drug projects; lead project-assigned staff as needed.
- Contribute to late clinical development planning (LDP) to ensure study designs meet program objectives plus worldwide regulatory and marketing needs.
- Identify and anticipate technical issues in clinical trial design, conduct, and analysis; propose and execute solutions.
- Develop protocols and data analysis plans; determine appropriate statistical methodology for analyses.
- Participate in worksheet development and database (collector/view) design to ensure unbiased, maximum-information data that satisfy analysis requirements.
- Determine statistical programming needs; organize programming to meet analysis requirements, internal SOPs, validation, and external regulatory requirements.
- Evaluate software suitability for planned analyses; identify needs for novel statistical methodology/program development.
- Analyze and interpret data to meet protocol objectives; apply basic and complex statistical techniques.
- Prepare oral and written reports for project teams, management, regulatory agencies, and investigators.
- Respond to study design/analysis/interpretation questions from clinical monitors, regulatory agencies, and investigators.
- Ensure accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participate in discussions with regulatory agency technical personnel and investigators.
- Collaborate in publication of research results.
- Independently conduct research to adapt and develop statistical methodology.
- Maintain and expand technical skills; present research at meetings and seminars; communicate with external statisticians.
- Recruit/train statisticians and provide statistical training to non-statistical groups as needed.
Qualifications
- Education: Ph.D. (preferred) or MS in Biostatistics or Statistics.
- Required experience: With an MS, 9+ years; with a Ph.D., 6+ years relevant work experience.
- Preferred experience: Leadership in clinical trial design/analysis; experience with regulatory filing for drug/vaccine products; regulatory submission experience strongly preferred; respiratory and immunology disease area experience desired.
Required skills
- Biostatistics, Clinical Trial Management, Clinical Trials/Analysis, Computing Software, Data Management/Data Science, Numerical Analysis, Regulatory Compliance/Requirements, Scientific Leadership, Scientific Modeling, SOPs, Statistical Analysis.
Application instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply no later than the day before the job posting end date indicated in the posting.
Benefits
- Annual bonus and long-term incentive (if applicable).
- Medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Responsibilities
- Develop, coordinate, and provide biostatistical support for drug projects; lead project-assigned staff as needed.
- Contribute to late clinical development planning (LDP) to ensure study designs meet program objectives plus worldwide regulatory and marketing needs.
- Identify and anticipate technical issues in clinical trial design, conduct, and analysis; propose and execute solutions.
- Develop protocols and data analysis plans; determine appropriate statistical methodology for analyses.
- Participate in worksheet development and database (collector/view) design to ensure unbiased, maximum-information data that satisfy analysis requirements.
- Determine statistical programming needs; organize programming to meet analysis requirements, internal SOPs, validation, and external regulatory requirements.
- Evaluate software suitability for planned analyses; identify needs for novel statistical methodology/program development.
- Analyze and interpret data to meet protocol objectives; apply basic and complex statistical techniques.
- Prepare oral and written reports for project teams, management, regulatory agencies, and investigators.
- Respond to study design/analysis/interpretation questions from clinical monitors, regulatory agencies, and investigators.
- Ensure accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participate in discussions with regulatory agency technical personnel and investigators.
- Collaborate in publication of research results.
- Independently conduct research to adapt and develop statistical methodology.
- Maintain and expand technical skills; present research at meetings and seminars; communicate with external statisticians.
- Recruit/train statisticians and provide statistical training to non-statistical groups as needed.
Qualifications
- Education: Ph.D. (preferred) or MS in Biostatistics or Statistics.
- Required experience: With an MS, 9+ years; with a Ph.D., 6+ years relevant work experience.
- Preferred experience: Leadership in clinical trial design/analysis; experience with regulatory filing for drug/vaccine products; regulatory submission experience strongly preferred; respiratory and immunology disease area experience desired.
Required skills
- Biostatistics, Clinical Trial Management, Clinical Trials/Analysis, Computing Software, Data Management/Data Science, Numerical Analysis, Regulatory Compliance/Requirements, Scientific Leadership, Scientific Modeling, SOPs, Statistical Analysis.
Application instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply no later than the day before the job posting end date indicated in the posting.
Benefits
- Annual bonus and long-term incentive (if applicable).
- Medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.