Principal Statistical Programmer (Vaccines)
ROLE OVERVIEW
Sanofi's Hyderabad Hub seeks a Principal Statistical Programmer to join the Vaccines Global Biostatistical Sciences team. This strategic role supports the entire vaccines R&D value chain—preclinical, clinical, translational, and CMC—by delivering compliant statistical programming outputs that drive regulatory submissions and health authority decisions. As part of a company producing over 500 million vaccine doses annually, you will lead complex programming activities, from study-level SDTM/ADaM specifications to integrated analyses for ISS/ISE, DSUR, and PBRER. This is a compelling opportunity to shape vaccine development, mentor junior talent, and work at the forefront of infectious disease prevention. If you thrive on scientific challenge and want to impact global public health, this role offers a dynamic, growth-oriented career path.
ROLE DEFINITION & RESPONSIBILITIES
- •Plan and execute high-quality statistical programming deliverables for vaccine studies, ensuring timely delivery aligned with project milestones.
- •Review study documents (protocol statistical sections, CRFs, SAPs) and provide feedback; create mock TLFs to guide analysis.
- •Write programming specifications for SDTM/ADaM datasets and TLFs, ensuring compliance with CDISC standards and health authority expectations.
- •Deliver compliant CDISC data packages including aCRF, reviewers guide, define.xml, and analysis results metadata.
- •At project level, review integrated analysis plans, create core integrated databases pooling SDTM/ADaM across studies for ISS/ISE/ISI, DSUR, PBRER, and safety surveillance.
- •Ensure TLF formats meet requirements for clinical study reports, publications, EudraCT, ClinicalTrials.gov, and lay summaries.
- •Lead and mentor junior staff, perform quality control, and maintain validation plans and QC documentation.
- •Propose and program exploratory/post-hoc analyses, and ensure compliance with SOPs, standards, and guidelines.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or related health sciences (or equivalent experience).
- 8+ years of statistical programming experience in clinical research, with some vaccines experience (designs, endpoints, statistical methods).
- Over 3 years of SAS programming: BASE, STAT, MACRO, GRAPH, SQL; familiarity with R.
- Proven experience programming CDISC SDTM/ADaM datasets, including writing specifications, P21, controlled terminology, value-level metadata, define.xml, and Reviewers Guide.
- Demonstrated success as a lead on several concurrent studies/projects; e-submission preparation strongly preferred.
- Ability to independently create specifications and knowledge of descriptive statistics.
- Strong communication skills in English, both oral and written.
PREFERRED QUALIFICATIONS
- •Vaccines-specific endpoints and designs
- •e-submission experience (eCTD)
- •Advanced SAS macro development
- •Mentoring junior programmers
- •Experience with DSUR/PBRER safety reporting
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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