Principal Scientist, Biostatistics, Clinical Safety Statistics

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.

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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:

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The salary range for this role is

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

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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.

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