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Sanofi
CMC Principal Statistician-Vaccines
• Waltham, Massachusetts, United States, Waltham
Job Title: CMC Principal
Statistician-Vaccines Location: Waltham, MA About the Job As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team providing statistical support to the mRNA CoE scientists/ SMEs (Subject Matter Experts) / engineers for process, formulation and analytics of mRNA Drug Substance (DS) and Drug Product (DP) ; as part of the Data and Computational Science team in the mRNA CoE. This team brings end to end data integration and advanced analytics (pre-clinical, biomarkers, process development, CMC, clinical) in the mRNA CoE. Deploying and exploiting digital solutions (AI/ machine learning, data, analytics) to integrate the full data value chain, extracting actionable information for a move to a full data driven strategy and decision-making process, to increase probability of success [...] of experiments, multivariate data analysis (PCA, PLS and related methods) , statistical modelling and simulation (including Machine Learning) is helpful Confirmed expertise in process modelling, batch evolution model, and process monitoring Mastery of statistical and mathematical software (R, Python, JMP,
Minitab. . . ) is helpful Knowledge on CMC regulatory guidelines (ICH Quality, Pharmacopeias) and white papers (ISPE, PDA) and experienced in preparing and presenting proposals and regulatory files to internal and external audiences, including regulatory authorities is required Scientific rigor, organization and proven project leadership Good networking skills and fluent interactions with one or more scientific communities, with strong communication and teaching skills is needed Understanding of vaccine development processes is a plus, as well as familiarity with RNA processes and RNA-centric techniques/ methods Fluent in English (French is a plus) Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s [...]
