Principal Biostatistician- Non-Clinical

Job title: Principal Non-Clinical Biostatistician

• Location: Hyderabad
  

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, 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.

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: Experience in 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 communicationskills.
  
• 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.
  
• 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
  

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.