Senior Stats Programmer (VAX)

Job title: Senior Statistical Programmer

• Location: Hyderabad

; 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. ; ReadyAs a Senior Statistical Programmer within our Hyderabad Hub, you;ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines RD value chain (Pre-Clinical, 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) or within a project (i.e.: ISS, ISE, ISI, DSUR, PBRER,)


• Review and provide feedback on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and 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


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


• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.


• Program exploratory and/or post;hoc analyses with minimum specifications


• Create core integrated clinical database, pooling SDTM/ADaM datasets across several studies within an asset


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

; ;;About you

• 5-7 years' experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, ;)


• SAS (>3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming


• Experience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)


• Experience pooling data from multiple studies according to existing specifications


• Experience planning and drafting specifications for pooling data from multiple studies


• Ability to independently create specifications


• Knowledge of descriptive statistics


• Good understanding of processes associated with clinical trials


• 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


• Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience


• English: Highly effective communication, both oral and written