Principal Biostatistician-Clinical Statistics

Job title: Principal Biostatistician

• Location: IN / 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 Principal Biostatistician within our Clinical Statistics Team, you'll Lead or support one or several early/late phase studies, 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?

Major Responsibilities:

• Support the clinical study design (including protocol development), the study setup and conduct.
• Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
• Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables) ...
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses.
• Review and examine statistical data distributions/properties
• Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team 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 function initiatives

About you

• Experience: Pharmaceutical or related industry experience with clinical trials.
• Soft skills: Demonstrated interpersonal and communication skills.
• Good knowledge and good understanding of statistical concepts and techniques
• Good knowledge of pharmaceutical clinical development
• Technical skills: Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
• Education: MS or PhD degree in Statistics or relevant fields
• Languages: Highly effective 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.
• Develop a career of being an influential statistician
• Gain international clinical trial experiences and communicate with Health Authorities worldwide.