Biostatistician Technical Expert - CMC Statistics

• Location: Barcelona

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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 a Biostatistician Technical Expert - CMC Statistics 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 global 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?

Job Summary

Assume responsibility for methodological and statistical aspects of multiple moderate Chemistry Manufacturing and Control (CMC) projects. Act as a statistical consultant within the study team and/or project team.

Main responsibilities:

In close collaboration with Statistical Project Leader and/or Group Head:

• Contribute to the reliability, scientific quality and optimization of project support regarding process development, by providing appropriate statistical support to CMC customers locally and remotely
• Bring statistical expertise and provide consulting for high quality experimental designs, data analysis and interpretation of results
• Perform statistical analyses of data from the laboratories using R and possibly other languages (SAS, ...) or standard statistical software used in Sanofi (JMP, SIMCA, Modde, internal tools), to deliver statistical reports/memo and presentations of statistical work package results to project team members and stakeholders
• Responsible for the statistical aspects of designing and analyzing complex or critical studies, generally intended to Health Authorities with writing of statistical study rapports in respect with internal policies and standards, external guidelines and processes
• Act as the Stat CMC statistics contact and local interface of the CMC Statistics group to related functions and customers
• Promote statistical thinking and culture within laboratories and deliver statistical training (methodology and tools); Support and train customers on validated statistical "end-user" applications. Train users on statistical methodology
• Contribute to develop state-of-the-art methodologies and statistical approaches on a variety of subjects needed for her/his field(s) of expertise, in partnership with other statisticians from the team and other groups of statisticians when appropriate. Participate to internal technical working groups and networks of statisticians
• Contribute to the harmonization of practices (including development and enhancement of guidelines from our partner organizations)
• Can act as Expert User for some internally developed applications
• Can contribute to the development and support of statistical end-user tools (mainly RShiny)
• Ensure productive collaborations with other functions in cross-functional teams and in communicating with senior leadership, promoting teamwork, quality, operational efficiency, and innovation
• Represent statistics in scientific or technology working groups or cross functional initiatives

About you

Experience:

• PhD/MS in statistics or related discipline with a minimum of 8 years for MS and 5 years for PhD of pharmaceutical experience as Statistician in CMC (Chemical Manufacturing and Control) studies/ activities, applying advanced statistical concepts to the validation of analytical methods , the development of product (e.g. stability modelling, comparability studies) to ensure state of the art quality and productivity
• Good knowledge of pharmaceutical development process
• Good expertise in the field of non-clinical statistics applied to CMC development (ex: Model qualification, Specifications limits calculation, Stability studies, analytical methods transfer)
• Good expertise of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation
• Experience in applying statistics for improving the process (e.g. modelling and monitoring of bio process)
• Experience in reporting and communicating plans, results, and conclusions in the form of technical documents and presentations

As a plus:

• Experience in performing complex exploratory statistical analyses with minimal specifications
• Experience in supporting analyses for regulatory filings and addressing Health Authorities questions

Soft and technical skills:

• Experience with statistical sciences applications, such as linear/non-linear models, design of experiments (DoE), multivariate analysis, control charts, modelling
• Able to work in departmental computing environment, do advanced statistical analyses using programming code such as R/RShiny, SAS or statistical software such as JMP, SIMCA, MODDE
• Excellent understanding of processes associated with CMC, GMP quality concepts (including ObD) used in pharmaceutical development and production
• Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles and ability to prepare statistical analysis for regulatory dossiers
• Demonstrate interpersonal and communication skills necessary for effective teamwork
• Scientific rigor and demonstrated level of independence to run statistical workpackages
• Education: MS or PhD in Statistics or relevant fields
• Languages: Excellent communication in English, both oral and written

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