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Principal Bio-Statistician-Non Clinical Statistic

2+ years
₹25–35 LPA
10 May 23, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Job Title: Principal Bio-Statistician – Non-Clinical Statistic
Location: Hyderabad
Employment Type: Permanent
Posting Date: May 05, 2025
Application Deadline: May 30, 2025


About the Job:

Join Sanofi’s R&D Data Sciences - CMC Statistics Department, where we focus on bringing innovation into pharmaceutical product development by supporting process, analytical methods, and formulation development across global sites. As a Principal Bio-Statistician – Non-Clinical Statistic, you will contribute to scientific rigor, process reliability, and strategic decision-making from early-stage development to regulatory submissions.


Key Responsibilities:

  • Statistical Support: Contribute to non-clinical statistical analysis throughout product development life cycle, from target identification to process development.

  • Analysis & Reporting: Perform statistical analysis using R, SAS, JMP, SIMCA, or other standard tools; deliver high-quality statistical reports and memos.

  • Tool Development: Support the creation of end-user statistical tools (primarily RShiny applications).

  • Methodology Advancement: Participate in internal groups to enhance statistical methodologies and apply state-of-the-art approaches.

  • Presentation: Effectively communicate statistical findings to project teams and stakeholders.

  • Compliance: Adhere to Sanofi’s internal policies and external regulatory guidelines.


Required Qualifications:

  • Education: Master’s degree in Statistics or a related discipline.

  • Experience:

    • Strong expertise in non-clinical statistics within biopharmaceutical development.

    • Proven skills in industrial statistics (SPC, DoE), multivariate data analysis (PCA, PLS), and simulation modeling.

    • Familiarity with CMC regulatory guidelines (EMA, FDA, ICH), and QbD principles.

    • Experience preparing statistical content for regulatory dossiers.

  • Technical Proficiency:

    • Proficient in statistical tools like R, SAS, JMP, SIMCA, and MODDE.

    • Able to work in a departmental computing environment.

  • Soft Skills:

    • Strong interpersonal and communication abilities.

  • Language: Fluent in English.


Why Join Us?

  • Be part of a supportive, international team working on high-impact pharmaceutical projects.

  • Get involved in regulatory and R&D statistical work across global Sanofi sites.

  • Benefit from a well-rounded rewards package, including:

    • Competitive compensation.

    • World-class healthcare and wellness programs.

    • 14 weeks’ gender-neutral parental leave.

  • Enjoy numerous career development opportunities, both locally and globally.

  • Thrive in a diverse and inclusive workplace committed to innovation and scientific excellence.


Estimated Salary: ₹25–35 LPA (based on role seniority and industry benchmarks in Hyderabad)