01Overview
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, youll 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 recent 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 TLFs 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 posthoc 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 .
