• Associate Director, Biostatistics

    Job Locations US-MA-Bedford
    Posted Date 5 months ago(4/23/2019 8:41 AM)
    Job ID
    2019-1217
    # of Openings
    1
    Category
    Clinical
  • Overview

    Provide leadership and guidance as the lead statistician and be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for oversight of outsourced statistical activities.

    Responsibilities

    •Serve as a biostatistics expert or point of contact for clinical studies
    •Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
    •Conduct statistical modeling and simulations to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
    •Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
    •Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings
    •Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
    •Design and specify randomization schedules; review and approve test randomization lists
    •Provide statistical input to data safety monitoring committee (DSMC) charters, independent review charters, and other study-level documents
    •Review analysis dataset specifications
    •Validate the results of key statistical deliverables
    •Perform ad hoc and exploratory statistical analyses as needed
    •Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results
    •Contribute to statistical activities in support of IND/NDA/MAA or other regulatory submissions
    •Provide statistical input to communications with the FDA and other regulatory agencies, and review and address comments by IRB/ECs
    •Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
    •Contribute to standardization and process improvement efforts

    Qualifications

    •Ph.D. in Biostatistics/Statistics, Applied Mathematics or equivalent degree
    •At least 6 years of experience in pharmaceutical, biotech, and/or CRO setting
    •In-depth programming skills of SAS, R, or other statistical software
    •Ability to understand and develop statistical and patient-based models, using the latest tools and methodologies
    •Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data

    • Strong statistical experience in clinical research and drug development
    •Experience in US and/or Non-US submissions
    •Strong communication and interpersonal skills; ability to interact with cross-functional teams

    •Ability to travel approximately 15%

     

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