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Internships At Pfizer – Associate Director Biostatistics Early Clinical Development Rare Disease In New York

    Website Pfizer

    Job Description:

    The Associate Director of Biostatistics will provide statistical support in one or more rare disease therapeutic areas (hematology, cardiology, nephrology, metabolic, or neurology), including pre-clinical and clinical development planning and execution for multiple indications in Pfizer’s expanding Rare Disease Research Unit. The position will be accountable for the robust planning and execution of (pre-)clinical development programs across numerous indications and therapeutic modalities (gene therapy, mRNA, small molecule, and biologics). The Associate Director will provide strategic input and leadership in relevant statistical areas such as external control matching, composite endpoint development, and other topics inherent in small-sample drug development.

    Job Responsibilities:

    • Core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality environment
    • Collaborate with various cross-functional scientists in the design, analysis and reporting of laboratory and early clinical studies in rare diseases
    • Frequently interact and engage with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need
    • Contribute to innovative statistical thinking and methods to help drive the Model Informed Drug Development paradigm within Pfizer. Central to this approach in the rare disease setting is the systematic review and incorporation of prior information (utilizing Bayesian methods as appropriate), statistical model building and simulation, and rigorous and robust use of external historical control data
    • Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives
    • Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types
    • Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment

    Job Requirements/Qualifications:

    • MSc (PhD preferred) in Statistics, Biostatistics, or related field
    • Minimum of 6 years’ experience applying statistical methods in the pharmaceutical industry, with early clinical (Phase I and Phase II) and translational experience in rare disease indications a definite advantage
    • Demonstrated competency with the design, implementation, analysis and reporting of clinical trials
    • Demonstrated strong communication skills, both oral and written
    • Experience with modeling and simulation and expertise in Model Informed Drug Development (MIDD) principles
    • Ability to proactively influence teams with innovative clinical development strategy

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