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    Associate Principal Scientist - North Wales, United States - Astrix

    Astrix
    Astrix North Wales, United States

    2 weeks ago

    Default job background
    Technology / Internet
    Description

    Type: Contract (2 years)

    Location: North Wales, PA (Hybrid)

    Pay: $58.68/hr

    Responsibilities:

    • Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals
    • Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies
    • Provide guidance on implementing COA/PRO instruments into studies by following Merck standard processes
    • Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs
    • Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies
    • Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies
    • Conduct literature searches to support COA/PRO endpoint strategies
    • Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.
    • Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.

    Qualifications:

    • PhD (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in Health Services Research, Statistics, Psychometrics, Outcomes Research (or closely related field) with relevant industry work experience in the COA field
    • Familiar with COA/PRO requirements for regulatory and reimbursement agencie
    • Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies.
    • Ability to understand and respond to multiple internal and external customers
    • Strong project management and communication skill
    • Experience with COA/PRO-related scientific presentations and publications.
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