PHARMAFull-time
Principal Biostatistician (VAX)
By Admin · Biostatistics & Statistical Programming
HYDERABAD (IN)ONSITEPOSTED: 9/3/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Support clinical study design (including concept protocol development), study setup, conduct, and reporting across the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC).
Act as accountable owner for all assigned statistical study deliverables: develop statistical sections in protocols (statistical methodology, sample size calculation), ensure statistical integrity, contribute to randomization specifications, develop Statistical Analysis Plans (SAP), plan and execute statistical data surveillance, and conduct data analysis.
Collaborate with the Project Biostatistician to interpret results, contribute to the Clinical Study Report (CSR), and ensure compliance with Transparency and Disclosure standards.
Develop Integrated Analysis Plans for Safety or Immunology Summaries; conduct related analyses with programming teams to deliver submission outputs for the Core Technical Dossier (CTD).
Partner with programming teams to define, document, and review derived variables and quality control plans; lead or coordinate the production of statistical analyses and CDISC-compliant data packages ready for regulatory submission.
Propose, prepare, and execute complex exploratory and ad-hoc data analyses to address study objectives or Health Authority queries.
Provide statistical insights into result interpretations relative to external studies and competitor data, using strong communication skills to explain methodology, consequences, and decisions to senior leadership and cross-functional teams.
Technical & Domain Standards
Ensure strict adherence to CDISC standards including SDTM, ADaM, SEND, specifications, Pinnacle 21 (P21), define.xml, and Reviewer's Guides.
Utilize SAS and R programming languages for complex statistical analyses and validation.
Maintain full alignment with vaccine trial designs, specific endpoints, and specialized vaccine statistical methods.
Leadership & Business Impact
Serve as lead biostatistician on multiple concurrent vaccine projects and studies.
Lead programming teams through e-submission activities including ISS, ISE, and ISI.
Represent biostatistics in scientific/technology working groups and cross-functional initiatives.
Drive operational efficiency, quality, innovation, and teamwork within the aligned study and safety monitoring teams.
Benefits & Total Rewards
Opportunity to work in a world-class global hub delivering over 500 million vaccine doses annually.
Access to advanced technologies and high-impact R&D value chain projects.
Highly supportive, future-focused, diverse, and inclusive work culture dedicated to professional development and global health impact.
REQUIRED VERIFIED SKILLS
Vaccines Trial Design
Biostatistics
SAS
R
CDISC
SDTM
ADaM
SEND
Sample Size Calculation
Statistical Analysis Plan (SAP)
Pinnacle 21
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Compensation for Principal Biostatistician roles requiring 8+ years of experience in global pharmaceutical R&D hubs in India generally commands a top-quartile market salary package. Total remuneration includes competitive fixed pay, performance-based annual incentives, and comprehensive corporate health and wellness benefits reflecting the senior nature of the role.
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
As a Principal Biostatistician at Sanofi's Hyderabad Hub, professionals are positioned on an executive technical track with opportunities to progress into Global Lead Biostatistician, Biostatistics Director, or R&D Leadership roles. The position offers deep exposure across the full R&D lifecycle (Pre-clinical to Regulatory Submission) and cross-functional collaboration, paving the way for international mobility and strategic domain consulting leadership within vaccine global health sciences.
APPLICATION ADVISORY
Ensure your resume explicitly highlights end-to-end Study Biostatistician ownership, including non-standard sample size calculations and regulatory e-submission packages (ISS/ISE/ADaM). Be prepared to demonstrate proficiency in both SAS and R, as well as hands-on experience defending statistical methodologies and SAP strategy to cross-functional stakeholders and Health Authorities.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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