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    Clinical Statistics Team Lead

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    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: Clinical Statistics Team Lead
    Location: Hyderabad, India

    About the Role:
    As a Clinical Statistics Team Lead at Sanofi, you will oversee a team of senior and principal biostatisticians, ensuring the statistical integrity and deliverables of clinical studies. You will be responsible for managing resources, planning and tracking project activities, and optimizing operational processes while providing leadership and training to junior staff.

    Key Responsibilities:

    • Support the clinical development plan (CDP), including clinical study design, protocol development, study setup, and conduct.
    • Oversee statistical analyses per the Statistical Analysis Plan (SAP) and ISAP, and ensure compliance with internal standards and regulatory guidelines.
    • Lead statistical deliverables for studies, including sample size calculations, randomization specifications, and statistical methodology.
    • Perform exploratory and ad-hoc analyses and contribute to transparency and disclosure deliverables.
    • Manage project timelines and ensure quality control in collaboration with the programming team.
    • Provide leadership in team performance reviews, training, and development.
    • Collaborate effectively with cross-functional teams and senior leadership to promote quality and operational efficiency.

    About You:

    • Experience: Proven experience in the pharmaceutical industry with strong project/study management and people management skills.
    • Skills: Expertise in advanced statistical techniques and knowledge of pharmaceutical clinical development. Experience with Artificial Intelligence or Generative AI is a plus.
    • Technical: Proficient in advanced statistical analyses using SAS and R.
    • Education: MS or PhD in Statistics or a relevant field.
    • Communication: Strong written and verbal communication in English.

    Why Sanofi?

    • Be part of a supportive, forward-thinking team that brings the miracles of science to life.
    • Access a range of growth opportunities, including international clinical trial experience and communication with Health Authorities.
    • Enjoy a comprehensive rewards package that prioritizes your health, well-being, and family.
    • Develop your career as an influential statistician and contribute to groundbreaking medical advancements.

    At Sanofi, we are committed to providing equal opportunities for all, regardless of background, and promoting diversity, equity, and inclusion in everything we do.

    Let’s pursue progress. And let’s discover extraordinary together.

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