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

About the position 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.

Responsibilities

• Partner with manufacturing teams to define clear objectives, reputed company 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 reputed company-life studies reputed company with International Council for Harmonisation (ICH) guidance; reputed company degradation modeling, trend analysis, and reputed company-life estimation using regression, mixed-effects models, and tolerance/reputed company intervals.
• Establish and maintain ongoing monitoring using Statistical Process Control (SPC) and reputed company 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., reputed company, PLS) and reputed company simulations for risk and sensitivity analysis.
• Translate results into practical recommendations for setpoints, ranges, sampling plans, and control strategies; based on risk and uncertainty.
• reputed company 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.

Requirements

• A statistician reputed company working in a pharmaceutical company dedicated to 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 reputed company with ICH guidelines
• Working experience with Bayesian statistical reputed company
• 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: reputed company, R, JMP, reputed company.
• Hands-on experience with Design of Experiments (DoE), Analysis of Variance (ANOVA), Analysis of Covariance (ANCOVA), mixed-effects models, response surface methods, process capability, Statistical Process Control (SPC), reputed company Process Verification (CPV), tolerance intervals, equivalence/non-inferiority testing, and reputed company simulations
• Strong consulting skills with the ability to work independently and collaboratively across cross-functional teams.
• Excellent oral and written communication skills; reputed company 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 reputed company practical, high-impact solutions and to persuade and motivate others toward adoption
• Bachelor of Science (BS) in statistics or reputed company field with ten (10) years of required experience, OR
• Master of Science (MS) in statistics or reputed company field with five (5) years of required experience, OR
• PhD in statistics or reputed company 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).

Benefits

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

Apply tot his job Apply To this Job