Senior Stats Programmer-Safety Programming

Job title: Sr Stats Programmer - R&D

• Location:IN / Hyderabad

About the job

The candidate will provide high quality statistical deliverables on projects for safety analytics purpose across Sanofi pharma therapeutic areas.

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 Senior Statistical Programmer within our Safety Center of Excellence, you’ll execute statistical deliverables on safety analytic domain.

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

• Execute high quality and timely statistical programming deliverables in the context of safety center of excellence (Integrated database, safety data analyses for Sanofi safety monitoring team and DSUR deliverables).

• Perform programming activities for all statistical programming deliverables on aggregate safety analyses across trials & INDs; with associated quality control, ensuring quality, timelines, technical validity, and compliance to internal standards, SOPs and regulatory requirements.

• Write and provide the programming specifications for the SDTM and ADaM for the integrated database, following the standard and specifications of the project mentioned by the project team.

• Build the Integrated Safety SDTM & ADaM Database (with associated metadata and programs), following the semi-automation tool.

• Provide trial level programming support for standard safety outputs.

• Contribute to the safety data visualization analyses for each project, based on the project specifications.  

About you

• Experience: Programming experience preferably in processing clinical trial data in the pharmaceutical industry

• Excellent knowledge of Good Programming Practices

• Technical skills in statistical programming, with knowledge in R (and SAS), and R Shiny

• Soft and technical skills: Knowledge on regulatory requirement evolution; thorough understanding of pharmaceutical clinical development.

• Ability to plan and perform the execution, reporting and documentation of all programming deliverables.

• Ability to work in team environment.

• Ability and mindset to embrace change, innovate and continuously improve programming practice.

• Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.

• Languages: Good verbal and written communication skills in an English global environment.

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.

• Join an international biopharma company

• Act within an international team on safety analytic domain, to deliver solutions for data integration and data visualization.

• Work on several compounds for multiple clinical therapeutic areas

“Join our Safety Center of Excellence as a Senior Statistical Programmer and play a pivotal role in executing high-quality safety analytics that drive innovation and contribute to saving lives worldwide, all while advancing your career in a supportive, growth-oriented environment.”