Principal Non-Clinical Biostatistician

About the job

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 a  Principal Non-Clinical Biostatistician within our Non Clinical Statistics Team at Hyderabad, you’ll Lead and support statistical activities for several Non-Clinical efficacy, safety studies or CMC activities, under minimum supervision of statistical team leader.

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:

• 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 or several studies or activities in the Non-Clinical development area.

• 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

• Review study plans (randomization, sample size, analysis) and reports for internal or external studies (e.g., Statistical Review of SPRs, technical reports, presentations) according to Sanofi best practices

• 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 

• Determine optimal design and sample size in particular for in vivo experiments in the scope of Animal Welfare committee (AWC) 

• Respect Policies, Standards, external guidelines and processes 

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

• 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 to participate in scientific or technology working groups or cross functional initiatives

About you

• Experience:

• • (MS) or (PhD) of pharmaceutical or related industry experience 

  • Strong expertise in the field of non-clinical 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:

• • Demonstrated excellent interpersonal and communication skills.  

  • Good knowledge and good understanding of statistical concepts and techniques, eg. predictive modeling, repeated measure ANOVA, multivariate analysis, dose response.

  • Good knowledge of pharmaceutical research and development, eg. in-vitro testing, animal models, toxicology studies

  • Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.

  • 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

• Education: MS or PhD in Statistics or relevant fields

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

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!