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Senior Non-Clinical Statistician (Efficacy & Safety) - Regulatory Cmc

2+ years
Not Disclosed
10 Nov. 15, 2024
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

Job Title: Senior Non-Clinical Statistician (Efficacy & Safety)
Location: Hyderabad

About the Job:

Join Sanofi's Biostatistics team as a Senior Non-Clinical Statistician and play a crucial role in transforming biopharmaceutical development. As a key contributor to early/late phase studies, you will provide statistical support across multiple stages of drug development, ensuring high-quality, reliable results.

Main Responsibilities:

  • Provide expert Non-Clinical statistical support to optimize projects from target identification to process development.
  • Manage statistical deliverables for assigned studies or activities in Non-Clinical development.
  • Perform statistical analysis of laboratory data using R and other tools like SAS, JMP, and SIMCA.
  • Review study plans and reports, ensuring compliance with Sanofi best practices.
  • Develop and support statistical end-user tools (mainly RShiny).
  • Collaborate in internal working groups to enhance statistical methodologies and approaches.
  • Contribute to optimal design and sample size determination for in vivo experiments in line with Animal Welfare Committee (AWC) standards.

About You:

  • Experience: Expertise in Non-Clinical statistics applied to biopharmaceutical development, including proficiency with RShiny and statistical analysis tools (SAS, R).
  • Skills: Strong understanding of statistical concepts, good communication, and interpersonal skills.
  • Education: MS or PhD in Statistics or relevant fields.
  • Languages: Proficient in English (oral and written).

Why Choose Us?

  • Global Impact: Contribute to the miracles of science and make a difference in people’s lives.
  • Career Growth: Opportunities to grow your career through promotions, lateral moves, or international assignments.
  • Comprehensive Benefits: Enjoy a well-crafted rewards package, health benefits, and wellness programs.

Pursue Progress. Discover Extraordinary at Sanofi.