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Fort Washington

    Statistical Programmer - Fort Washington, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Fort Washington, United States

    3 weeks ago

    Default job background
    Description
    Responsibilities:
    • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
    • Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
    • Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
    • Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
    • Responsible for validity of analysis and explore alternative analysis strategies as needed.
    Requirements:
    • 4+ years' experience preferred leading late phase studies.
    • MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience.
    • Must have experience in AdAM.
    • Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
    • Infectious disease background + experience working on observational studies.
    • Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
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