Principal Biostatistician - Non-Clinical CMC

• 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 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 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?

Main responsibilities:

Under 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/memo

• Contribute 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 approaches

• Respect Policies, Standards, internal and external guidelines and processes

• Presentation of statistical work package results to project team members and stakeholders

About you

Experience:

• 4+ years (MS) or 2+ years (PhD) of pharmaceutical or related industry experience 

• Basic knowledge of pharmaceutical development process and analytical methods

• Strong expertise in the field of CMC statistics applied to biopharmaceutical development

• Proven 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

Soft and technical skills:

• Scientific rigor and demonstrated level of independence to run statistical workpackages

• Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), QbD principles and ability to prepare statistical analysis for regulatory dossiers

• Use of standard commercial software e.g. JMP, SIMCA, MODDE

• Able to work in departmental computing environment, do advanced statistical analyses using R, SAS and possibly other languages (Python, …)

• Excellent interpersonal and communication skills

• Education : MS or PhD in Statistics or relevant fields

• Languages: Excellent communication in English, both oral and written

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