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    Director Biostatistics - Boston, United States - Green Key Resources

    Green Key Resources
    Green Key Resources Boston, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Director Biostatistics Role Overview:

    As the Director of Biostatistics, you will lead and manage all biostatistics activities for clinical programs. Your main goal is to ensure timely and precise delivery of statistical designs, analyses, and reports for regulatory submissions. This key role involves providing strategic statistical input throughout the drug development process, contributing to compound level program strategies, and representing Biostatistics in project teams.

    Responsibilities:

    • Lead and manage internal and external biostatistics and statistical programming resources
    • Ensure accurate and statistically valid deliverables in various documents
    • Coordinate major statistical milestones and deliverables
    • Provide statistical leadership for various aspects of clinical development
    • Apply innovative statistical approaches to study design and analysis
    • Stay updated on advancements in relevant fields
    • Monitor project progress and resource allocation

    Requirements:

    • A PhD in Statistics/Biostatistics with 7 years of experience or a MSc with 10 years of experience
    • Knowledge of statistical methodology, regulatory requirements, and software programs
    • Experience with BLA/NDA submissions and CDISC requirements
    • Excellent communication and interpersonal skills
    • Ability to work well under pressure in an office-based environment


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