Job Description

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 and to accelerate mRNA vaccines and therapeutics development and launch. Main Responsibilties: Represent the mRNA CoE Data and Computational Science team in platform and project technical teams as statistical CMC subject matter expert and develop and drive strategic CMC initiatives within the DS/DP and CMC data strategy. Ensures high reliability, quality, and optimisation by providing an appropriate statistical support and guidance to process development, analytical and CMC teams in both GMP and non-GMP studies. Bring broad statistical expertise and innovation around computational and statistical approaches towards mRNA process development and analytics for projects and cross-platform optimization (use of in silico methods – statistical modelling, simulation, machine learning - for improving bioprocess yields, biophysical stability, and safety profiles of mRNA vaccines and therapeutics). Bring broad statistical expertise in the design of experimental protocols, in the realization and interpretation of the results of statistical analyses and their presentation, automation and standardisation. Design and execute the statistical analysis of complex or critical studies, which might be intended to Health Authorities with writing of statistical study rapports according to the established practices/standards and to participate to the answer to the questions from the Agencies on the registration dossiers and on various regulatory variations/commitments. Participate in training of scientists to statistical methods and to the use of validated « end-user » statistical applications. Contribute strategically in global initiatives of harmonization of the practices (within the mRNA CoE and within the partner organizations). Maintains a well-documented, reusable codebase, and traceable model history. Maintains awareness of latest developments in relevant fields, evaluates and applies as warranted. Generates IP and participates in the drafting of patent filings. Lead preparation and publication of scientific papers and congress reports. Demonstrate good software engineering practices. Proactively identify, assess, and internalize emerging technologies and methods. About You: Earned PhD in Statistics or other related STEM field required. Recognized leader with at least 5 years’ experience in the field of non-clinical statistics applied to biopharmaceutical development and manufacturing is required. Experience collaborating with process and analytical scientists and engineers on the development of biotherapeutics, ideally in the following domains: Experimental designs in the context of the development and of the qualification/validation of processes following the QbD approach (selection of experimental design matrices, statistical analysis/modelling of results). Statistical modelling & simulation of DS/DP processes. Statistical process control (univariate & multivariate). Validations & transfers of analytical methods (protocols, statistical analysis). Statistical analysis of DS and DP characterization and activity tests, stability studies, and comparability studies. Statistical analysis performed in a GxP environment. Mastery of industrial statistics (descriptive & inferential statistics, statistical process control), design 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).

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