Job Description

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

Non-Clinical Senior Biostatistician

within our Statistics Team in Hyderabad, you'll Support statistical activities for several Non-Clinical efficacy, safety studies or CMC activities, under 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
About you

Experience

: + (Master) or (PhD) of pharmaceutical or related industry experience
+ 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

: + Expertise in the field of non-clinical statistics applied to biopharmaceutical development
+ Demonstrated excellent interpersonal and communication skills.
+ Good knowledge and good understanding of statistical concepts and techniques
+ Good knowledge of pharmaceutical research and development
+ Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
+ Expertise in JMP JSL script; RShiny hosting on GitHub
+ 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

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