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 Principal Statistical Programmer within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D; value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team.
We are an cutting-edge global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main responsibilities:




Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project
At study level for various analyses within a study:
Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create mock TLFs
Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives
Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations
At project level for various analyses within an asset:
Review and provide feedback on integrated analysis plan and create mock TLFs
Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance
Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study rep

📌 Principal Stats Programmer (Hyderabad)
🏢 Sanofi
📍 Hyderabad