Principal Scientist, Biostatistics, Clinical Safety Statistics

MSD Malaysia; Northern (KY); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays, vacation, and sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, and North Wales PA, United States, seeks a Principal Scientist in Biostatistics for Clinical Safety Statistics to lead safety analyses across oncology programs.

You will develop methodologies and collaborate with RMSTs to evaluate safety throughout the product life cycle. The role requires a PhD in statistics/biostatistics with 6+ years of experience or a master’s with 9+ years, strong SAS/R, and regulatory knowledge.

Qualifications

• PhD or equivalent with 6+ years of relevant work experience or master’s with 9+ years of relevant work experience.
• Strong knowledge of statistical methods and regulatory requirements for safety data analysis.
• Experience in clinical trial design and analysis, including integrated safety data, is required.

Responsibilities

• Lead safety monitoring and evaluation within CSS for Oncology programs.
• Provide statistical leadership to RMSTs for compound-level safety evaluations.
• Design and implement innovative statistical methods and tools for safety evaluation.

Skills

Biostatistics

Statistical analysis

Survival analysis

Meta-analysis

Bayesian methods

Propensity score

SAS or R

Regulatory knowledge

Clinical trial design

Education

PhD in statistics/biostatistics

Master's in statistics/biostatistics

Tools

SAS

R

Job description

## Principal Scientist, Biostatistics, Clinical Safety StatisticsApply: Hybrid: USA - Pennsylvania - North Wales (Upper Gwynedd): USA - New Jersey - Rahway: Full time: Posted Today: End Date: October 4, 2026 (3 days left to apply): R420043**Job Description****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 develop strategic and statistical plans and conduct analyses of safety data from clinical trials and post-marketing sources for drug and vaccine development programs. Their work informs product safety profiles and benefit-risk assessments throughout the product life cycle. **Key Responsibilities for this Position:** Lead safety monitoring and evaluation within CSS for key Oncology Therapeutic Area programs. Provide statistical leadership and support to Risk Management Safety Teams (RMSTs) in planning and executing compound-level safety evaluations throughout the product life cycle. Design, develop, and implement innovative statistical methods and tools for safety evaluation. **Primary Activities:** * Provide statistical leadership for compound safety evaluation strategies and analyses in the Oncology Therapeutic Area; support CSS projects in other therapeutic areas as needed.* Partner with Clinical Safety Risk Management, Early and Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and conduct aggregate safety evaluations for oncology projects.* Ensure that safety deliverables meet analysis requirements, applicable SOPs, and regulatory guidance.* Communicate safety analysis results and recommendations to cross-functional 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 a related discipline with at least 6 years of relevant work experience, or a master’s degree with at least 9 years of relevant work experience. **Required:** * Strong knowledge of statistical methods, including survival analysis, meta-analysis, Bayesian methods, and approaches to control confounding, such as matching and propensity score analysis. Proficiency in statistical software, such as SAS or R.* Strong knowledge of regulatory requirements for analyzing and reporting safety data.* Knowledge of and experience in clinical trial design and analysis, including the analysis and interpretation of integrated safety data.* Knowledge of statistical methods for analyzing randomized and nonrandomized clinical trial and real-world data.* Strong communication, project management, and leadership skills, including the ability to influence cross-functional teams and align priorities across the therapeutic area. **Preferred:** * Knowledge of the drug and vaccine development process, from discovery and preclinical research through Phase 1–3 clinical trials, NDA review, and post-marketing evaluation.* Interest in developing or applying novel statistical methods for safety data monitoring, evaluation, and benefit-risk assessment, with publications in peer-reviewed statistical or medical journals.* Knowledge of and experience in developing or applying AI tools in drug development projects.* Understanding of disease biology.BARDS2020#eligibleforERP**Required Skills:**Biostatistics, Clinical Trials, Data Management, Data Science, Numerical Analysis, Scientific Modeling, Statistical Analysis**Preferred Skills:**Current Employees apply HERECurrent 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 RightsEEOC GINA SupplementWe 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 ActsThe salary range for this role is$190,800.00 - $300,300.00This 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**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:**Hybrid**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**n/a**Job Posting End Date:**10/4/2026**\\*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.