Senior Biostatistician Early Clinical

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 Senior Biostatistician Early Clinical within our Early Clinical Statistics Team at Hyderabad, you’ll support one or several early phase studies, 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:

• Support the clinical study design, 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: 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.

About you

Experience:

• 3+ years (Master) or 1+ years (PhD) of pharmaceutical or related industry experience with clinical trials
• Soft and technical skills:
• Demonstrated interpersonal and communication skills.
• Broad knowledge and good understanding of key statistical concepts and techniques, eg. two one-sided tests (TOST), mixed effect models, factorial designs, and PK/PD modelling.
• Good knowledge of pharmaceutical clinical development, eg. first in human studies, BA/BE, dose finding and dose escalation, food effect, hepatic/renal impairment.
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.

Education: MS or PhD in Statistics or relevant fields

Languages: Excellent communication in English, both oral and written