Stats Programmer (Vaccine)

Job title: Stat Programmer (Vaccine)

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 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 (PreClinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team. We are an innovative 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:

• Perform programming activities for all statistical deliverables (i.e.: SDTM, ADaM, Tables Listings and Figures (TLF)) for various analyses within a study (e.g.: interim/final analyses, internal or external data monitoring committees, statistical surveillance)

• Review and provide feedback on study documents such as Case Report Form, Statistical Analysis Plan (SAP), mock TLFs, programming specifications

• Write or review programming specifications for the SDTM/ADaM/TLFs to fulfil the study objectives

• Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations

• Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)

• Contribute to quality control for statistical programming deliverables and complete the associated documentation

• Might contribute to core integrated clinical database programming, pooling across several studies within an asset

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

About You

• Experience: Should Have at 2 + Years of experience in clinical statistical programming.

• Should Have experience on vaccine therapeutic area in clinical statistical programming.

• Soft Skill & Technical Skill: technical skills in SAS/BASE, STAT, MACRO

• Experience on programming CDISC SDTM/ADaM datasets according to existing specifications (including running and resolving P21 compliance checks) is must.

• Ability to work according to existing specifications.

• Demonstrate an understanding of processes associated with clinical trials and statistics.

• Demonstrate interpersonal skills necessary for effective teamwork.

• Demonstrate ability to organize multiple work assignments and establish priorities.

• Demonstrate critical thinking skills beyond simply following directions or specifications