Senior Biostatistician- Safety

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 Safety Biostatistician within our Clinical Safety CoE Statistics Team in Hyderabad, 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

SANOFI has put in place a Systematic Safety Surveillance Approach to ensure an efficient safety surveillance for patients. The Safety Statistical Analyst is responsible to provide leadership and support on statistical analysis deliverables for various projects Safety Monitoring Teams (SMT), under limited supervision from the Head of Safety Center of Excellence (CoE) or the project statistician. Based on the Safety Surveillance Plan (SSP) and/or Aggregated Safety Statistical Plan (ASSAP), you will plan and execute statistical analyses with high quality and timely delivery.

Main responsibilities:

Provide support to the project safety monitoring team on all assigned statistical and programming matters:

Provide high quality input in ASSAP for standard projects.

Take responsibility for all safety statistical analysis deliverables (e.g. for SMT, DSUR/PBRER) in standard projects, overseeing production, coordination, and reviewing statistical data distributions/properties. Execute the safety statistical analyses, ensuring adherence to the SSP and ASSAP, provide statistical insight into interpretation and discussion of results to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.

Propose, prepare and perform exploratory safety data analyses, as relevant for the study or project objectives

Contribute to the building the Integrated Safety SDTM & ADaM Database in close collaboration with the safety programmer. Provide definitions, documentation, and review of derived variables, as well as the quality control plan

Contribute to operational process optimization.

Set up safety data visualization analyses based on project specifications.

Participate to Safety Monitoring Team Meetings. Ensure productive collaborations with other functions in the aligned safety monitoring team, promoting teamwork, quality, operational efficiency, and innovation.

Collaborate with safety programmer and statistical project team to achieve project goals.

About you

Experience:

o At least 3 years of biostatics and/or clinical trial data analysis experience in a pharma /CRO company.

o Sound knowledge of pharmaceutical clinical development (i.e. statistical concepts, techniques and clinical trial principles) and on regulatory requirement evolution. Ideally, have a first experience in multiple therapeutic areas and in safety signal detection.

Soft and technical skills:

o Demonstrated strong project/study management, interpersonal and communication skills

o Able to work in departmental computing environment. Advanced technical skills in statistical analysis, with advanced knowledge in SAS, R, and preferably R Shiny

o Knowledge on regulatory requirements and industry standards, e.g., SDTM, SDRG, ADRG, ADAM, XML format, etc. and working experience in producing such deliverables.

o Ability to plan and manage multiple competing timelines.

o Problem solving skills that demonstrate initiative and motivation in a global collaboration environment.

o Ability and mindset to embrace change, innovate and continuously improve practice

Education: MS in statistics or related discipline.

Languages: Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with colleagues across geographical location.