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Biostatistician Technical Expert - Clinical Statistics

5-7 year years
Not Disclosed
10 Sept. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Biostatistician Technical Expert – Clinical Statistics

Location: Hyderabad, India
Department: Clinical Statistics


About Sanofi

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. At Sanofi, you’ll find countless opportunities to grow, collaborate, and push the boundaries of science and innovation.

Join us, and be part of transforming healthcare while advancing your own career.


Role Overview

As a Biostatistician Technical Expert - Clinical Statistics, you will lead and oversee statistical support for senior and principal biostatisticians, ensuring high-quality statistical deliverables across multiple early and late-phase studies. You will guide study teams in applying advanced statistical methods, ensure scientific integrity, and collaborate across functions to drive impactful outcomes.


Key Responsibilities

  • Clinical Development Support: Contribute to the clinical development plan (CDP), study design, and protocol development.

  • Statistical Analyses: Lead/oversee execution of statistical analyses per SAP/ISAP, prepare statistical methodology, and ensure integrity of results for CSR and publications.

  • Mentorship & Expertise: Act as a biostatistical consultant, mentor junior statisticians, and provide guidance on advanced methodologies.

  • Regulatory Compliance: Maintain awareness of evolving regulatory requirements and trial methodologies, ensuring compliance with SOPs and standards.

  • Deliverables Ownership: Accountable for statistical sections of protocols, SAP, randomization, data surveillance, estimands, and final analysis reports (tables, listings, figures).

  • Exploratory Analyses: Perform ad-hoc and exploratory analyses aligned with study or project objectives, including transparency and disclosure deliverables.

  • Collaboration: Partner with programmers to produce and QC statistical outputs.

  • Process Optimization: Contribute to statistical processes, quality standards, and cross-functional initiatives.

  • Representation: Represent the statistics team in scientific, technological, or cross-functional forums.


About You

Experience

  • 7+ years (MS) or 5+ years (PhD) in the pharmaceutical industry.

  • Experience in project management and clinical development preferred.

Technical & Soft Skills

  • Broad expertise in advanced statistical concepts and techniques.

  • Strong project/study management, interpersonal, and communication skills.

  • Knowledge of clinical development across early, late-phase, and post-marketing settings.

  • Proficiency in SAS and R; ability to apply advanced statistical methods.

  • Knowledge/experience with Artificial Intelligence or Generative AI is a plus.

Education

  • MS or PhD in Statistics or a related field.

Languages

  • Excellent oral and written communication in English.


Why Join Us?

At Sanofi, your growth matters as much as the work we do. Together, we’ll:

  • Pursue progress and chase the miracles of science.

  • Challenge convention and build smarter healthcare solutions.

  • Drive impact that reaches millions of lives worldwide.

We are committed to Diversity, Equity, and Inclusion (DE&I) and provide equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, veteran status, or any other protected characteristic.


👉 Ready to pursue progress and discover extraordinary?
Join Sanofi today.