Principal Scientist, Biostatistics, Clinical Safety Statistics

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. Statisticians in the Clinical Safety Statistics (CSS) group strategize, plan and analyze safety data from clinical trials and post-marketing sources for drug and vaccine development programs to help inform the safety profile and benefit-risk understanding of products throughout their life cycle. Key Responsibilities for this Position: Serve as the CSS therapeutic area lead for the vaccine and infectious disease (VID) projects. Provide statistical leadership and support to the Risk Management and Safety Teams (RMSTs) in the strategic planning and execution of compound level safety evaluation across product life cycle in vaccine and drug programs Design, develop and implement innovative statistical methods and tools for safety evaluation. Primary Activities: Provide statistical leadership for compound safety evaluation strategy and analysis in vaccines and infectious diseases; support CSS projects in other therapeutic areas as needed. Partner with Clinical Safety Risk Management, Early/Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and execute on aggregate safety evaluation in vaccine and drug projects Ensure safety deliverables meet analysis requirements, relevant SOPs and regulatory guidance. Communicate safety-analysis results and recommendations to teams, management, regulators, and investigators. Develop processes, job aids, statistical methods, and tools for safety evaluation that address scientific and business needs Education: PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or master’s with a minimum of 9 years relevant work experience. Required: Solid knowledge of statistical analysis methodologies. Solid experience of using statistical software (eg SAS or R). Solid knowledge of regulatory requirements regarding the analysis and reporting of safety data. Strong project management and leadership skills, including the ability to influence cross-functional teams and align priorities at the Therapeutic Area level. Knowledge of and experience with clinical trial design and analysis. Experience with the analysis and interpretation of integrated safety data Knowledge of statistical methods appropriate for the analysis of clinical trial data in both randomized and non-randomized studies Preferred: Solid Knowledge of drug/vaccine development process from discovery, preclinical research, clinical trials (Phase 1, 2 and 3), NDA review to post-marketing evaluation Knowledge and experience in developing/applying AI tools in drug and vaccine development projects. BARDS2020 #eligibleforERP Required Skills: Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Numerical Analysis, Safety Management, Statistical Analysis, Statistical Software, Strategic Management, Strategic Planning Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $190,800.00 - $300,300.00 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 You can apply for this role through (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 Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 07/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.