Senior Statistical Programmer (Vaccines R&D)
ROLE OVERVIEW
Sanofi's Hyderabad Hub anchors the company's global Vaccines R&D biostatistics capability, and the Senior Statistical Programmer role sits at the analytical core of that mission. With more than 500 million vaccine doses delivered annually, Sanofi depends on rigorous, submission-ready statistical evidence spanning pre-clinical, clinical, translational and CMC workstreams. This position partners directly with the Vaccines Global Biostatistical Sciences team, converting raw trial data into CDISC-compliant SDTM and ADaM datasets, pooled integrated databases, and the Tables, Listings and Figures that underpin regulatory filings, DSURs, PBRERs and publications. It is a compelling opportunity for an experienced programmer who wants scientific depth rather than generic coding, exposure to global health-authority expectations, and a visible line of sight between their code and millions of patients protected from infectious disease.
ROLE DEFINITION & RESPONSIBILITIES
- •Program and validate SDTM, ADaM and TLF deliverables for interim and final analyses, internal/external data monitoring committees and statistical surveillance.
- •Write programming specifications for SDTM/ADaM datasets and mock TLFs that fulfil study and project objectives.
- •Review protocol statistical sections, CRFs, Statistical Analysis Plans and mock shells, providing actionable programming feedback.
- •Deliver compliant CDISC data packages including annotated CRF, define.xml, Reviewers Guide and value-level metadata.
- •Build pooled integrated clinical databases across studies within an asset for ISS, ISE, ISI, DSUR and PBRER submissions.
- •Perform independent quality control, author validation plans and complete associated QC documentation.
- •Program exploratory and post-hoc analyses from minimum specifications and emerging stakeholder requests.
- •Ensure compliance with SOPs, CDISC controlled terminology, standards and transparency publishing requirements such as clinical study reports, EudraCT, CT.gov and lay summaries.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science or a related health sciences discipline.
- 5–7 years of hands-on statistical programming experience in clinical research, ideally with prior vaccines exposure.
- Minimum 3+ years of advanced SAS (BASE, STAT, MACRO, GRAPH, SQL) plus working proficiency in R.
- Proven track record programming and specifying CDISC SDTM/ADaM datasets, including vaccine-specific constructs.
- Demonstrated ability to pool data from multiple studies and to plan and draft pooling specifications.
- Solid grounding in descriptive statistics and end-to-end clinical trial processes.
- Highly effective oral and written English communication for cross-functional global teamwork.
PREFERRED QUALIFICATIONS
- •Vaccine trial design and immunogenicity endpoint expertise
- •Experience with Metadata Repositories (MDR) and standards governance
- •Familiarity with BLA/MAA submission lifecycle
- •Python or cloud-based analytical environment exposure
- •Prior CRO or global pharma hub experience
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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