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Principal Biostatistician (Vaccines)

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

ROLE OVERVIEW

This Principal Biostatistician role at Sanofi's Hyderabad Hub sits at the heart of Vaccines Global Biostatistical Sciences, supporting the entire R&D value chain from preclinical through clinical, translational, and CMC activities. As Sanofi delivers over 500 million vaccine doses annually and pursues a robust vaccine portfolio, this position ensures every study design, analysis, and submission package is statistically rigorous and regulatory-ready. The biostatistician will influence protocols, integrated summaries, and CDISC-compliant data packages that answer Health Authority questions. It is a compelling opportunity for an experienced statistical leader to shape vaccine development, collaborate with global programming and clinical teams, and drive data-driven decisions that protect millions of patients worldwide. This role also offers exceptional visibility across global submissions and health authority interactions.

ROLE DEFINITION & RESPONSIBILITIES

  • •Support clinical study design, concept protocol development, study setup, conduct, and reporting across vaccine R&D programs.
  • •Author statistical sections in protocols, including methodology and sample size calculations, and ensure each study is statistically sound.
  • •Contribute to randomization specifications and set-up, then develop and finalize the Statistical Analysis Plan for assigned studies.
  • •Plan and execute statistical data surveillance, perform analyses, and interpret results with the Project Biostatistician.
  • •Ensure clinical study report statistical integrity and deliver all transparency and disclosure outputs for regulatory submissions.
  • •Develop Integrated Analysis Plans for Safety or Immunology Summaries and conduct related analyses with programming support.
  • •Define, document, and review derived variables plus the quality control plan; oversee production of CDISC-compliant data packages.
  • •Propose and perform complex exploratory or ad-hoc analyses for Health Authority questions, and represent statistics in cross-functional working groups.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • PhD or Master's degree in Statistics (preferred), Mathematics, or a related health science; equivalent experience may be considered.
  • 8+ years in clinical biostatistics and programming research, including 3-5 years in vaccine trial designs, endpoints, and statistical methods.
  • End-to-end experience as Study Biostatistician: non-standard sample size, protocol statistical sections, randomization set-up, SAP, analyses, and study reports.
  • Proven record leading programmers through e-submission statistical activities such as ISS, ISE, or ISI.
  • Experience performing complex exploratory statistical analyses without written specifications and leading several concurrent studies.
  • Strong SAS and R programming skills plus knowledge of CDISC (SDTM/ADaM/SEND), P21, define.xml, and Reviewers Guide.

PREFERRED QUALIFICATIONS

  • •P21 and define.xml
  • •Reviewers Guide Preparation
  • •Complex Exploratory Data Analysis
  • •Project Management for Concurrent Studies
  • •Cross-Functional Leadership in Global Teams

REQUIRED VERIFIED SKILLS

Clinical Biostatistics
CDISC SDTM/ADaM/SEND
SAS Programming
R Programming
Statistical Analysis Plan (SAP) Development
Sample Size Calculation
Randomization Specifications
Integrated Safety/Immunology Summaries
Health Authority Submissions (ISS/ISE/ISI)
Vaccine Clinical Trial Design

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 Biostatistician, high performers can progress to Senior Principal Biostatistician, Biostatistics Team Lead, or Global Statistical Sciences Director within Sanofi's Hyderabad Hub or global vaccines group. In 2-5 years, you may lead a therapeutic area portfolio, manage biostatistics programmers, and own submission strategies. The role builds deep expertise in vaccine statistics, CDISC, and regulatory interactions, opening exit options at CROs (IQVIA, Parexel, Syneos), Indian pharma vaccines players (Serum Institute, Bharat Biotech, Biological E), and global R&D hubs. You could also move into health authority liaison, biometrics leadership, or independent statistical consulting. Sanofi's scale and vaccine pipeline provide exceptional visibility for accelerated advancement.

APPLICATION ADVISORY

Tailor your resume to show end-to-end ownership of vaccine studies: protocol statistical sections, sample size justifications, SAPs, randomization, CDISC datasets, and ISS/ISE experience. Highlight SAS and R proficiency plus specific vaccines endpoints and health authority interactions. Prepare to discuss non-standard sample size methods, missing data strategies, and how you led programmers through submissions. Review ICH-GCP, CDISC (SDTM/ADaM), and define.xml. Be ready to explain complex exploratory analyses in plain language and demonstrate cross-functional leadership in global teams.
RECOMMENDED TRAINING
1/3
QA/QC Fundamentals

QA/QC Fundamentals

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