Principal Biostatistician- Non-Clinical

Job title: Principal Biostatistician- Non-Clinical

• Location: IN / Hyderabad
   

About the job

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, modeling, digitalization, decision-making and filing of new product registration files.

Our 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 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?

Job Summary

Main responsibilities:

Under supervision of Statistical Project Leader and/or Group Head, contribute to the reliability, scientific quality and optimization of project support from target identification to process development, by providing appropriate Non-Clinical statistical support:

Accountable for all assigned statistical deliverables related to one study or activities in the Non-Clinical development area:

• Elaborate Designs of Experiments and define statistical approaches according to study objectives
• Perform statistical analyses of data from the laboratories using R and possibly other languages (SAS, …) or standard statistical software used in Sanofi (JMP, SIMCA, 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, external guidelines and processes
• Presentation of statistical work package results to project team members and stakeholders

About you

• Strong expertise in the field of non-clinical statistics applied to synthetics development (ex: Model qualification, Specifications limits calculation, Stability studies, analytical methods transfer)
• Basic knowledge of pharmaceutical research and development process
• Scientific rigor and demonstrated level of independence to run statistical workpackages
• For positions supporting Process Development/CMC consider the following:
  • 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
  • Knowledge of CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias), GMP practices, QbD principles and ability to prepare statistical analysis for regulatory dossiers.
  • Use of standard commercial software e.g. JMP, SIMCA, MODDE and R/RShiny coding

• Able to work in departmental computing environment, do advanced statistical analyses using R and possibly other languages (SAS, …)
• Excellent interpersonal and communication skills
• Master in statistics or related discipline
• Fluent in English

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 through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of an international collaborative team
• Work for several sites and varied departments
• Be involved in crucial statistical activities for the company like in the regulatory dossiers

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!