Principal Stats Programmer (VAX)
Sanofi · Hyderabad
- Experience8–9 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelexecutive
- Posted24 Sept 2026
About Sanofi
Sanofi is hiring in Hyderabad in pharma biotech. This role looks for around 8+ years of experience.
Skills
- SAS
- CDISC
- SDTM
- ADaM
- R
- SQL
- Statistical programming
- Statistical methods
- Clinical trials
- Quality control
- Project management
The role
A statistical programmer works in vaccine research and healthcare. They plan and execute clinical-trial analyses using SAS and CDISC, create SDTM and ADaM datasets, and deliver TLFs and regulatory submission documentation across studies. Their defining skills are SAS, CDISC, and clinical-trial programming, alongside R, SQL, statistical methods, exploratory analysis, quality control, and e-submission preparation.
Full job description
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 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
Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine projectAt 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 TLFsWrite and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectivesDeliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectationsAt project level for various analyses within an asset:Review and provide feedback on integrated analysis plan and create mock TLFsCreate core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillanceEnsure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)Take leadership, guiding more junior staff and ensuring quality and timely deliveriesPerform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.Propose and Program exploratory and/or post’hoc analyses based on problem statementEnsure compliance to SOP's, standards, and guidelines.
About You
You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:
Experience:8+ 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 programmingExperience 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 in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solutionExperience pooling data from multiple studies according to existing specificationsExperience planning and drafting specifications for pooling data from multiple studiesConsistent successful experience as a lead on several concurrent studies/projectse-submission preparation experience strongly preferred
Skills:Good understanding of processes associated with clinical trialsAbility to independently create specificationsKnowledge of descriptive statisticsDemonstrate interpersonal skills necessary for effective teamworkDemonstrate ability to organize multiple work assignments and establish prioritiesDemonstrate critical thinking skills beyond simply following directions or specificationsAbility to lead complex and large tasks, demonstration of strong project management skills
Education:Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experienceLanguages:English: Highly effective communication, both oral and written