Principal Stats Programmer-Safety Programming

Job title: Principal Stats Programmer

• Location: IN / Hyderabad

About the job

The candidate will provide high quality statistical deliverables on projects, across Sanofi pharma therapeutic areas, for safety analytics purpose. Working on several clinical compounds, the candidate will provide expertise on safety data integration for data visualization integrated solution.

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 Statistical Programmer within our Safety Center of Excellence, you’ll develop statistical deliverables for safety analytics on clinical projects.

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:

• Plan and execute high quality and timely statistical programming deliverables in the context of safety center of excellence (Integrated database, safety data analyses for 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 (propose to the Safety statistical Programmer Leader the validation plan and completes the associated documentation: Validation plan and quality control (QC) documentation), ensuring quality, timelines, technical validity, and compliance to internal standards, SOPs and regulatory requirements.

• Review and provide feedbacks on Aggregated Safety Analysis Plan (ASAP) document.

• Participate to the kickoff meeting between project team and Safety CoE.

• 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.Set-up the safety data visualization analyses for each project, based on the project specifications.

• Collaborate with safety statistician and safety statistical project leader, and with project team in the aligned project team to achieve project goals.

About you

• Experience: Should have at least 5 Years of experience in end-to-end statistical programming with hands on ADAMs & TLFs.

• Must have experience of working as Study lead programmer.

• Must have experience of CRT package creation or ISS/ISE submission experience.

• Excellent knowledge of Good Programming Practices. Advanced technical skills in statistical programming, with advanced knowledge in R (and SAS), and R Shiny

• Knowledge on regulatory requirement evolution; thorough understanding of pharmaceutical clinical development (i.e. statistical concepts, techniques and clinical trial principles). Ideally, have a first experience in multiple therapeutic areas.

• Soft and technical skills: Ability to plan and perform the preparation, execution, reporting and documentation of all programming deliverables.

• Ability to work in team environment with emphasis on internal team management.

• Ability to support multiple assignments with challenging timelines under direct supervision by the safety statistical programming project leader.

• Problem solving skills that demonstrate initiative and motivation in a global collaboration 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: Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with colleagues across geographical locations.

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 Principal Statistical Programmer and lead the execution of high-quality safety analytics, driving innovation and contributing to global health improvements, all while advancing your career in a supportive, growth-oriented environment.”