Sr. Statistician – Chemistry, Manufacturing, and Controls (CMC)

Job Description

Under the general supervision of a senior staff member in Center for Mathematical Sciences (CMS), the incumbent is responsible for the statistical analysis and evaluation of data to meet the needs of our company’s Manufacturing Division. The individual will, through consultation with employees and teams, provide statistical expertise on experimental design, and the evaluation and interpretation of data. As required, the incumbent will evaluate data for submission to regulatory agencies and pharmacopoeia.

Primary Activities

• Partner with manufacturing teams to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (e.g., ANOVA, ANCOVA, mixed-effects models).
• Design and analyze experiments using Design of Experiments (DoE) to understand, optimize, and qualify/validate vaccine manufacturing processes and analytical methods.
• Support scale-up, technology transfer, and comparability with sound protocols, acceptance criteria, and statistical justifications.
• Analyze stability and shelf-life studies aligned with International Council for Harmonisation (ICH) guidance; perform degradation modeling, trend analysis, and shelf-life estimation using regression, mixed-effects models, and tolerance/prediction intervals.
• Establish and maintain ongoing monitoring using Statistical Process Control (SPC) and Continued Process Verification (CPV) for Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs); implement control charts (e.g., X-bar/R, Individuals-Moving Range), capability analysis (Cp/Cpk/Pp/Ppk), and nonparametric trend tests as needed.
• Troubleshoot issues, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results, using data analysis, root-cause hypotheses, and targeted confirmation studies; apply multivariate methods (e.g., PCA, PLS) and Monte Carlo simulations for risk and sensitivity analysis.
• Translate results into practical recommendations for setpoints, ranges, sampling plans, and control strategies, based on risk and uncertainty.
• Develop reproducible, auditable analysis using good manufacturing/documentation practices.
• Prepare clear statistical content for Chemistry, Manufacturing, and Controls (CMC) documentation; assist with regulatory queries using sound statistical rationales.

Minimum Education Requirements and Experience

• Bachelor of Science (BS) in statistics or related field with ten (10) years of required experience, OR
• Master of Science (MS) in statistics or related field with five (5) years of required experience, OR
• PhD in statistics or related field with no required experience.

Please note: Coursework and/or experience should include industrial statistics (DOE, SPC, regression, general linear models, and multivariate methods, computer programming).

Required Skills and Experience

• Experience as a statistician in a pharmaceutical company supporting vaccine manufacturing, emphasizing critical thinking, domain knowledge, and scientific partnership.
• Demonstrated experience supporting Chemistry, Manufacturing, and Controls (CMC) activities for drug substance and drug products, including stability studies, comparability assessments, process validation, and control strategy development aligned with ICH guidelines.
• Working experience with Bayesian statistical framework.
• Background in mammalian cell culture and yeast fermentation.
• Proficient in live virus potency (plaque assays, TCID50, qPCR/dPCR) and recombinant protein analytics (ELISA, HPLC/UPLC).
• Excellent statistical computing skills with substantial experience in at least two of the following statistical software packages: SAS, R, JMP, Minitab.
• Hands-on experience with DoE, ANOVA, ANCOVA, mixed-effects models, response surface methods, process capability, SPC, CPV, tolerance intervals, equivalence/non-inferiority testing, and Monte Carlo simulations.
• Strong consulting skills with the ability to work independently and collaboratively across cross-functional teams.
• Excellent oral and written communication skills; able to explain statistical concepts and results to non-statisticians and influence decision-making.
• Proven leadership with advanced problem-solving and decision-making skills; adept at managing multiple projects, meetings, time, and priorities.
• Ability to think originally and creatively to develop practical, high-impact solutions and to persuade and motivate others toward adoption.

Required Skills

Accountability, Bayesian Statistics, Business Intelligence (BI), Capability Analysis, Cell-Based Assays, Cell Cultures, Computer Programming, Control Charts, Data Analysis, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning (ML), Mammalian Cell, Mammalian Cell Culture, Manufacturing, Manufacturing Processes, Manufacturing Support, Mixed Models, Response Surface Methodology, SAS Language, Software Development {+ 9 more}