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  • Associate Director, Biostatistics - San Francisco County, CA - Proclinical Staffing

    Proclinical Staffing
    Proclinical Staffing San Francisco County, CA

    6 days ago

    Default job background
    Description

    A highly impactful role is available for an Associate Director, Biostatistics to join a leading Biotech company in the Bay Area.

    This exciting opportunity will see you working on shaping the future of healthcare and science, capitalizing on successful Regulatory approvals and an extensive pipeline.

    Key Responsibilities:

    • Lead the execution of statistical components of Development programs, managing external statisticians and statistical programmers.

    Requirements:

    • D. in Statistics, Biostatistics, or Mathematics
    • 7+ years of experience in clinical trial development
    • Demonstrated ability for project management of projects in clinical development
    • Experience managing delivery of statistical projects by CROs

    Job Duties:

    • Work alongside Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials in the portfolio.
    • Oversee execution of the statistical components of clinical studies by CROs and independent contractors.
    • Manage on-time and quality delivery of CRO-generated analyses results.
    • Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation statistical analyses results generated by CROs.
    • Partner with Statistical Programming in the evaluation of CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness.
    • Consult internal audit team in assessing regulatory compliance of CROs with respect to statistical SOPs.
    • Participate in standards governance and development of Biostatistical SOPs.

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Associate director, biostatistics