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    Associate Director of Biostatistics - South San Francisco, United States - TotalMed, Inc.

    TotalMed, Inc.
    TotalMed, Inc. South San Francisco, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Salary: $190,000 to $240,000

    On-Site: South San Fran, CA

    Responsibilities:

    • Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams
    • Oversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leader
    • Responsible for writing statistical methodology section of the protocol, including sample size calculation
    • Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
    • Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
    • Direct the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards
    • Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents
    • Participate in operations meetings, project team meetings, and address issues related to biostatistics
    • Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports
    • Perform ad hoc analysis and data validation
    • Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting

    Qualifications

    • Master's degree in statistics or biostatistics with 8+ years of biopharmaceutical statistics experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry
    • Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time
    • Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
    • Knowledge of missing data handling, multiple comparisons, and simulation techniques
    • Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
    • Good working knowledge of ICH, FDA and GCP regulations and guidelines
    • Strong leadership skills and teamwork spirit
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