Senior Statistician – Chemistry, Manufacturing, and Controls (CMC) | Merck & Co., Inc.
Location: U.S. (Hybrid, minimal travel – 10%)
Job Reference: R373127
Experience Required: Varies by degree:
BS in Statistics: 10+ years relevant experience
MS in Statistics: 5+ years relevant experience
PhD in Statistics: No prior experience required
Education Required: BS/MS/PhD in Statistics or related field
Salary Range: $126,500 – $199,100 + annual bonus and long-term incentives
Job Type: Regular
Company Overview
Merck & Co., Inc., a global leader in biopharmaceuticals, drives innovation in vaccine and drug development. The Center for Mathematical Sciences (CMS) provides advanced statistical expertise to support Chemistry, Manufacturing, and Controls (CMC) processes, ensuring product quality, regulatory compliance, and scientific rigor.
Role Summary
The Senior Statistician – CMC will provide advanced statistical analysis and consultation to the Manufacturing Division. This role applies Design of Experiments (DoE), Statistical Process Control (SPC), regression analysis, and multivariate methods to optimize vaccine and drug manufacturing, evaluate critical quality attributes (CQAs) and process parameters (CPPs), and support regulatory submissions.
The role requires strong collaboration with cross-functional teams and the ability to translate statistical insights into actionable decisions that improve manufacturing quality, efficiency, and compliance.
Key Responsibilities
Statistical Analysis & Process Optimization
Partner with manufacturing teams to define objectives, success criteria, and decision points for process studies.
Apply ANOVA, ANCOVA, mixed-effects models, and response surface methods for process and analytical evaluation.
Design, analyze, and optimize experiments using DoE to qualify and validate vaccine manufacturing processes and analytical methods.
Support scale-up, technology transfer, and comparability studies with statistical justification.
Analyze stability and shelf-life data aligned with ICH guidance, including degradation modeling and trend analysis.
Implement SPC and Continued Process Verification (CPV) for CQAs and CPPs, including capability analysis and control charts.
Data Interpretation & Decision Support
Troubleshoot OOS/OOT results using statistical methods, root-cause analysis, multivariate approaches (PCA, PLS), and Monte Carlo simulations.
Translate data into practical recommendations for setpoints, ranges, sampling plans, and control strategies.
Develop reproducible and auditable analyses adhering to Good Manufacturing Practices (GMP).
Documentation & Regulatory Support
Prepare clear statistical content for CMC documentation and assist with regulatory queries.
Collaborate with cross-functional teams to provide statistical expertise for process validation, comparability, and control strategy development.
Required Qualifications & Experience
Advanced knowledge in industrial statistics: DoE, SPC, regression, GLMs, multivariate methods.
Proficiency in statistical computing software (SAS, R, JMP, Minitab).
Hands-on experience in Bayesian statistics, mixed models, Monte Carlo simulations, process capability, tolerance intervals, and non-inferiority testing.
Experience supporting CMC activities for drug substances and products, including stability, comparability, validation, and control strategy development.
Background in mammalian cell culture, yeast fermentation, live virus potency assays, and recombinant protein analytics.
Strong consulting and communication skills to explain complex statistical concepts to non-statisticians.
Demonstrated leadership and ability to manage multiple projects, meetings, and priorities.
Preferred Qualifications
Experience in vaccine manufacturing support in a pharmaceutical environment.
Proven ability to develop practical, high-impact solutions in collaboration with cross-functional teams.
Familiarity with ALCOA+ principles, GMP documentation, and regulatory submission processes.
Core Skills & Competencies
Advanced Statistical Analysis & Modeling
Chemistry, Manufacturing, and Controls (CMC) Expertise
Design of Experiments (DoE)
Statistical Process Control (SPC) & Continued Process Verification (CPV)
Process Validation & Optimization
Regulatory Submissions & Documentation
Data Analysis, Interpretation & Visualization
Cross-Functional Team Collaboration
Problem-Solving & Decision-Making
Work Environment & Benefits
Hybrid work model (three days on-site, Monday–Thursday; Friday remote).
Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and sick leave.
Annual bonus and long-term incentive eligibility.
Inclusive, diverse, and collaborative work culture fostering innovation.
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