Associate Principal Scientist, Biostatistics, Clinical Safety Statistics Full-time

Associate Principal Scientist, Clinical Safety Statistics (CSS)

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.

Associate Principal Scientist, Clinical Safety Statistics (CSS), Biostatistics and Research Decision Sciences (BARDS), Statisticians in the Clinical Safety Statistics (CSS) group analyze safety data from clinical trials for drug and vaccine development programs to help inform the safety profile of products throughout their life cycle.

Responsibilities:

• Provide statistical support and leadership for projects related to the evaluation of clinical safety data.
• Interact with cross-functional Risk Management Safety Teams (RMSTs) on planning and executing evaluations of safety data for clinical development programs.
• Design, develop and evaluate processes, methods and tools for safety data evaluation.

Primary activities:

• Collaborate with Clinical Safety and Risk Management, Clinical Research, Early Development Statistics, Late Development Statistics, Epidemiology, Scientific Programming, and other groups, on drug/vaccine safety evaluation from the Investigational New Drug (IND) through New Drug Application (NDA) to post-marketing phases of development programs.
• Provide statistical support and leadership to cross-functional RMSTs for strategic planning and statistical analysis activities supporting safety evaluations.
• Collaborate on planning and executing aggregate safety evaluations for: clinical trials during a development program, regulatory documents (e.g., DSUR, IB), and responses to safety-related inquiries. Ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements.
• Evaluate the appropriateness of available software for planned analyses and ascertain the need for development of novel statistical methods or programming.
• Design, develop and evaluate processes, methodology and tools for product safety evaluation to support ongoing aggregate safety data analysis.
• Prepare oral and written reports and presentations to effectively communicate safety analysis results to project teams, management, regulatory agencies, or individual investigators.
• Stay current regarding regulatory guidance and methods for the evaluation of safety data.
• Participate in research activities for innovative statistical methods and applications in clinical safety evaluation.

Education:

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or master's with a minimum of 6 years relevant work experience.

Required:

• Solid knowledge of statistical analysis methodologies, including survival analysis, meta-analysis and Bayesian analysis methods.
• Knowledge of and experience with clinical trial design and analysis.
• Knowledge of and experience with the analysis and interpretation of (integrated) safety data.
• Knowledge of and experience with the specifications, creation, and use of SDTM and ADaM datasets.
• Solid knowledge of statistical and data processing software e.g. SAS and/or R and R-Shiny, including generation of statistical graphics.
• Ability to function effectively in a team environment with personnel from different functional areas.
• Strong oral and written communication, organizational, and project management skills.

Preferred:

• Knowledge of statistical methods for the analysis of observational (epidemiologic) data, including methods to control confounding (e.g., matching, propensity score analysis, etc.)
• Knowledge of regulatory requirements regarding safety signal evaluation, identification, and reporting.
• Knowledge of drug development process from Discovery, Preclinical Research, Clinical Trials (Phase 1, 2 and 3), NDA review, through post-market safety monitoring.
• An interest in statistical research activities particularly those related to the development and application of novel methods for safety data monitoring, evaluation, and benefit-risk assessment.
• Publications in peer reviewed statistical/medical journals.
• An understanding of disease biology and drug discovery and development.
• Expertise with AI to facilitate writing (summaries, reports, manuscripts, etc.), programming, and other types of tasks.

Required Skills: Clinical Development, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Drug Development, Numerical Analysis, Product Safety, Regulatory Requirements, Safety Databases, SAS Language, Scientific Modeling, Statistical Graphics, Statistics, Survival Analysis, Veterinary Medicine, Waterfall Model

Preferred Skills:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $142,400.00 – $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 03/17/2026

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