Job Description Sr. Statistician – Chemistry, Manufacturing, and Controls (CMC) – R3 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 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, capability analysis, 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 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 CMC documentation; assist with regulatory queries using sound statistical rationales. Minimum Education Requirements and Experience Bachelor of Science in statistics or related field with ten (10) years of required experience. Master of Science in statistics or related field with five (5) years of required experience. PhD in statistics or related field with no required experience. Coursework and/or experience should include industrial statistics (DOE, SPC, regression, general linear models, and multivariate methods, computer programming). Required Skills and Experience Experienced statistician working in a pharmaceutical company and supporting vaccine manufacturing, with strong critical thinking, domain knowledge, and scientific partnership. Demonstrated experience supporting Chemistry, Manufacturing, and Controls 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, TCID 50 , qPCR/dPCR) and recombinant protein analytics (ELISA, HPLC/UPLC). Excellent statistical computing skills with substantial experience in at least two of the following software packages: SAS, R, JMP, Minitab. Hands‑on experience with those statistical methods listed above, including mixed‑effects models, response surface methods, process capability, SPC, CPV, tolerance intervals, non‑inferiority testing, and Monte Carlo simulations. Strong consulting skills with 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 persuade and motivate others toward adoption. Required Skills Accountability, Bayesian Statistics, Business Intelligence, 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, Mammalian Cell, Manufacturing, Mixed Models, Response Surface Methodology, SAS Language, Software Development. Preferred Skills None listed. Equal Employment Opportunity Statement 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. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid work model consisting of three total days on site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require an on‑site presence. This model does not apply to field‑based, manufacturing‑based, or research‑based positions where in‑person attendance is required, as well as positions covered by a collective‑bargaining agreement or designated “remote.” Salary $126,500.00 – $199,100.00 Benefits Comprehensive package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Application Process Apply through our job site. The application deadline is stated on the posting. Travel Requirements 10% Requisition ID
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