Principal Statistical Programmer

HYDERABAD (IN)HYBRIDPOSTED: 9/25/2026
PHARMAFull time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
Sanofi

ROLE OVERVIEW

Sanofi Business Operations in Hyderabad is an internal global capability hub that centralises biostatistics, medical affairs and HEVA support for Sanofi's Specialty Care, Vaccines, General Medicines and R&D franchises. As a Principal Statistical Programmer, you become the technical anchor for statistical outputs that reach regulators, payers and physicians — transforming raw clinical trial and registry data into QC'd tables, figures and listings that underpin abstracts, posters, manuscripts and ad-hoc analyses. This is a genuinely strategic role: the quality of your SDTM and ADaM datasets directly influences how convincingly Sanofi communicates evidence for its pipeline. It is a compelling opportunity for an experienced programmer who wants global stakeholder exposure, formal mentorship responsibilities and the autonomy to design non-routine macros and advanced analytical techniques inside a world-class life-sciences environment.

ROLE DEFINITION & RESPONSIBILITIES

  • •Implement statistical analysis plans from Medical Affairs biostatisticians, delivering QC'd tables, figures and listings for abstracts, posters, oral presentations and manuscripts.
  • •Design, develop, test, implement and document SAS programs and non-routine macros that automate complex, repeatable statistical outputs.
  • •Conduct post-hoc statistical analyses of clinical trial and registry data to answer ad-hoc Medical Affairs and scientific communications requests.
  • •Create and validate SDTM and ADaM datasets in line with CDISC standards and Sanofi SOPs across multiple therapeutic areas.
  • •Develop and execute project QC plans with Global Medical Affairs biostatisticians to guarantee double-programming accuracy and audit readiness.
  • •Manage multiple conflicting high-priority deadlines, proactively communicating timeline risks and delivery status to local and global stakeholders.
  • •Coach and mentor new team members and support graduate hiring programmes to accelerate onboarding and capability building.
  • •Remain current on advanced programming methods and contribute to process improvement initiatives across the biostatistics function.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Master's degree in Statistics, Mathematics, Computer Science, Life Sciences or Engineering with a minimum of 6 years of relevant statistical programming experience.
  • Or a Bachelor of Science degree with a minimum of 8 years of hands-on clinical statistical programming experience.
  • Proven hands-on expertise in advanced SAS programming (Base, Macro, SQL, STAT) within a clinical trial, registry or real-world data environment.
  • Practical experience building and validating SDTM and ADaM datasets according to CDISC standards.
  • Demonstrated exposure to multiple therapeutic areas and global biostatistics workflows.
  • Excellent written and spoken English, with the ability to document programming decisions and QC rationale clearly.
  • Strong stakeholder management skills, autonomy in managing activities, and comfort working independently or within cross-functional teams.

PREFERRED QUALIFICATIONS

  • •R or Python for statistical programming and reproducibility
  • •Therapeutic experience in Vaccines, Specialty Care or General Medicines
  • •Medical Affairs publication support (abstracts, posters, manuscripts)
  • •Mentoring, coaching or graduate programme facilitation
  • •Experience in global capability centres or offshore delivery models

REQUIRED VERIFIED SKILLS

Advanced SAS Programming (Base, Macro, SQL, STAT)
CDISC SDTM and ADaM Standards
Statistical Analysis Plan (SAP) Implementation
Tables, Figures and Listings (TFL) Production
Double Programming and QC Validation
Macro Development and Automation
Clinical Data Environment and EDC Familiarity
ICH-GCP and Regulatory Submission Awareness
Stakeholder Management
Registry and Real-World Data Analysis

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

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.

TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology

EXPECTED CAREER ROADMAP

From Principal Statistical Programmer, the natural next step is a Lead or Associate Director-level statistical programming or biostatistics role, owning a therapeutic-area portfolio and shaping programming standards across a global capability centre. Within two to three years, high performers often move into line management, standards governance (CDISC define.xml, metadata repositories) or statistical science leadership. Sanofi's Hyderabad hub also offers lateral mobility into clinical data management, real-world evidence, HEOR or medical affairs analytics. Externally, this profile is highly portable: CROs such as IQVIA, Parexel, Fortrea, ICON and Syneos, plus captive centres at Novartis, Pfizer, AstraZeneca, Amgen and Bristol Myers Squibb, actively recruit Principal and Lead statistical programmers in India, frequently at a 20–35% compensation premium.

APPLICATION ADVISORY

Tailor your CV around outputs, not tools: quantify the number of studies supported, TFLs delivered and therapeutic areas covered. Expect a technical assessment involving SAS macro writing, a dataset merge or an ADaM derivation question, plus a discussion of how you build a validation and QC plan. Highlight SDTM and ADaM mapping decisions you personally made and how you resolved conflicting stakeholder deadlines. Brush up on current CDISC Implementation Guide versions and define.xml. Prepare one concise example of mentoring a junior programmer or automating an inefficient process, and articulate clearly why Medical Affairs publication support appeals to you.

READY TO SUBMIT?

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