Location: BarcelonaOur Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready?As part of the development of Sanofi’s pharmaceutical products, the R&D Data Sciences department and more specifically the Statistics department for the Chemical Manufacturing Control (CMC), CMC Statistics, is responsible for contributing to statistical support, modelling, digitalization, decision-making and filing of new product registration files.As Principal CMC statistician within our Data Sciences/ CMC Statistics you’ll be supporting the CMC activities for process, analytical methods and formulation development, for several CMC sites in the world.We are an innovative general healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Principal CMC statisticianMain ResponsibilitiesUnder supervision of Statistical Project Leader and/or Group Head, contribute to the reliability, scientific quality and optimization of project support from Cell Lines to Biologics License Application, by providing appropriate CMC statistical support:Accountable for all assigned statistical deliverables related to one study or activities in the CMC development area:Perform statistical analyses of data from the laboratories mainly, using R and SAS,



and possibly other languages, or standard statistical software used in Sanofi (JMP, SIMCA, Modde, internal tools), to deliver statistical reports/memoContribute to the development and support of statistical end-user tools (mainly RShiny )Participate to internal working groups and contribute to develop state-of-the art methodologies and statistical approachesRespect Policies, Standards, internal and external guidelines and processesPresentation of statistical work package results to project team members and stakeholdersExperience4+ years (MS) or 2+ years (PhD) of pharmaceutical or related industry experienceBasic knowledge of pharmaceutical development process and analytical methodsStrong expertise in the field of CMC statistics applied to biopharmaceutical developmentProven expertise of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulationSoft And Technical SkillsScientific rigor and demonstrated level of independence to run statistical workpackagesKnowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles and ability to prepare statistical analysis for regulatory dossiersUse of standard commercial software e.G. JMP, SIMCA, MODDEAble to work in departmental computing environment, do advanced statistical analyses using R, SAS and possibly other languages (Python, …)Excellent interpersonal and communication skillsEducationMS or PhD in Statistics or relevant fieldsLanguagesExcellent communication in English, both oral and writtenTags#BarcelonaHub #SanofiHubs#J-18808-Ljbffr

📌 Principal Biostatistician - Non-Clinical Cmc (Madrid)
🏢 Talantir
📍 Madrid