Senior Principal Scientist, Biostatistics
Location: Rahway, NJ
Employment type: Full-time
Seniority level: Director
Job function: Research, Analyst, and Information Technology
Job Description
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state‑of‑the‑art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
Responsibilities
- >Serve as a statistical lead in project teams.
- Lead, develop, coordinate, and provide biostatistical support for related drug/vaccine projects in Late Development Statistics.
- Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Scientists from our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- Interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- The incumbent may initially work in a specific disease area.
Primary Activities
- Serve as statistical representative and lead in cross‑functional teams for strategic planning and execution of product development.
- Lead a team of statistical and/or programming staff assigned to a development project as needed.
- Lead biostatistics in early or late clinical development planning to ensure study designs meet worldwide regulatory and marketing needs.
- Identify and anticipate technical or other potential problems arising in design, conduct, and analysis of clinical trials, propose solutions, and carry them out.
- Develop individual protocols and data analysis plans and independently determine appropriate statistical methodology for analysis.
- Lead a team of statisticians and statistical programming staff to ensure all programs meet analysis requirements, internal SOPs, and external regulatory requirements.
- Evaluate appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology.
- Analyze data and interpret results from clinical trials to meet objectives of the study protocol; independently apply and implement basic and complex statistical techniques to these analyses.
- Prepare oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
- Represent biostatistics in regulatory interactions including presentation at advisory committee meetings.
- Provide responses to queries relating to study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, and/or investigators.
- Participate in departmental activities including recruiting and training other statisticians, providing statistical training for non‑statistical groups, and committee work as needed.
Education & Minimum Requirements
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
Required Skills And Experience
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership in design and analysis of clinical trials.
- Strong project management skills.
- Solid knowledge of statistical and data processing software (e.g., SAS and/or R).
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Excellent oral and written communication skills and strong leadership in a team environment.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
- Publications in peer‑reviewed statistical/medical journals.
- Must also demonstrate the ability to learn, be proactive, and motivated, consistently focusing on details and execution.
Preferred Skills And Experience
- Experience in immunology and/or respiratory therapeutic area is desirable.
- Must also demonstrate the ability to learn, be proactive, and motivated, consistently focusing on details and execution.
Salary and Benefits
Salary range: $206,200.00 – $324,600.00. Eligible for annual bonus and long‑term incentive if applicable. Comprehensive benefits include medical, dental, vision, 401(k), paid holidays, vacation, and compassionate and sick days. Hybrid work model: 3 days on‑site per week, with office location in Rahway, NJ.
EEO Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC .
How to Apply
Apply for this role through Merck Careers by 12/1/2025.
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