Principal Scientist, Biostatistics – Clinical Safety Statistics

MSD

Principal Scientist in Biostatistics driving clinical safety analysis for vaccines and infectious diseases. Leading statistical methods and communicating results with cross-functional teams.

Posted 7/9/2026full-timeNorth Wales • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $190,800 - $300,300 per yearWebsite

About the role

Key responsibilities & impact

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
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

Requirements

What you’ll need

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
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

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Statistical AnalysisSafety Data EvaluationStatistical Methods DevelopmentData InterpretationRegulatory Compliance

Soft Skills

Leadership SkillsInfluencing Cross-Functional TeamsCommunication Skills