R&D - Principal Stats Programmer

Job title: Principal Stats Programmer

Location : IN / Hyderabad

Grade: L2-2

Hiring Manager: Cindy MARABOTTI

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. ReadyAs 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

About the job

Plan and execute high quality and timely statistical programming deliverables within a study (from phase II).

Programming Study Lead (SP) of a study(ies). With limited direction from programming project leader, plan and execute statistical programming activities for the responsible study.

• Perform programming activities for all statistical deliverables within a study/project, e.g. ADaM, Tables Listings and Figures (TLF) for Data Monitoring Committee Reports (DMC, if any), Interim Analysis (if any), Clinical Study Report, Transparency (Eudract, CTGov, Lay Summary), Statistical Surveillance, Publications and any exploratory analyses.

• Perform quality control for statistical programming deliverables, propose to the PPL the validation plan and completes the associated documentation: Validation plan and quality control (QC) documentation.

• Review and provide feedbacks on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and Table Listing and Figures (TLF) templates.

• Write and provide the programming specifications for the Study Data Tabulation Model (SDTM) and Analysis Datasets Model (ADaM) for a study.

• Provide support to the preparation of eSub package relative to HA questions.

• Ensure compliance to SOP s, standards, and guidelines.

• Collaborate with study statistician and PPL on SAP, analyses and with data management team on data issues.

About you

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

• Soft Skills Technical Skills : Knowledge about clinical development programs

• Knowledge on regulatory requirement evolution. Advanced technical skills in statistical programming, with advanced knowledge in R (and SAS), and R Shiny, in a clinical data environment across multiple therapeutic areas, thorough understanding of relational databases and their correlation to submission-ready database structure (CDISC data structure requirements)

• Excellent knowledge of Good Programming Practices. Proven communication and coordination skills. Ability to plan and perform the preparation, execution, reporting and documentation of all programming deliverables of a study. 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 programming project lead. 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

• Language: Excellent written and good verbal communication skills in an English global environment

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

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.

Cindy MARABOTTI

Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !