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Principal Biostatistician- Non-Clinical

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: Principal Non-Clinical Biostatistician

Location: Hyderabad

About the Job:

At Sanofi, we are driven by the desire to chase the miracles of science to improve people’s lives. As a Principal Non-Clinical Biostatistician, you will lead and support statistical activities for non-clinical efficacy, safety studies, and CMC activities, with minimal supervision. Join us in transforming the future of healthcare and making a significant impact on millions of lives.

Main Responsibilities:

  • Provide statistical support for Non-Clinical studies, ensuring reliability, scientific quality, and optimization.
  • Accountable for statistical deliverables related to Non-Clinical development studies.
  • Perform statistical analyses using tools such as R, SAS, JMP, and SIMCA, and deliver statistical reports and presentations.
  • Review study plans, randomization, sample size, and analysis reports, ensuring adherence to best practices.
  • Contribute to the development and support of statistical end-user tools, mainly RShiny.
  • Participate in cross-functional teams and internal working groups to drive innovation and improve methodologies.
  • Ensure collaboration with various functions to promote quality, operational efficiency, and teamwork.

About You:

  • Experience: Strong expertise in non-clinical statistics applied to biopharmaceutical development.
  • Skills: Advanced statistical analysis using SAS, R, and other languages. Expertise in statistical modeling, design of experiments, and multivariate data analysis.
  • Education: MS or PhD in Statistics or relevant fields.
  • Knowledge: In-depth understanding of CMC regulatory guidelines (EMA, FDA, ICH Quality) and QbD principles.

Why Choose Us?

  • Endless opportunities for growth, both professionally and personally.
  • Thoughtful rewards package and a comprehensive range of health and wellbeing benefits.
  • Supportive team, career development opportunities, and gender-neutral parental leave.
  • Join a diverse and inclusive organization where extraordinary progress happens.