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Basking Ridge

    Associate Director, Biostatistics - Basking Ridge, United States - Daiichi Sankyo

    Daiichi Sankyo
    Daiichi Sankyo Basking Ridge, United States

    1 week ago

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    Description
    Job Description

    Join a Legacy of Innovation 110 Years and Counting


    Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.

    With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.

    Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

    Summary

    Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision.

    This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.

    This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.

    Responsibilities


    • Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.
    • Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.
    • CRO /

    Vendor Oversight:
    Review CRO/vendor proposal and budget.

    Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.

    Ensures deliverables are accurate and delivered according to the timelines.

    • Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities
    • Global BDO Strategy to

    Improve Drug Development:

    Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.


    Qualifications:
    Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

    Education Qualifications (from an accredited college or university)


    • PhD in statistics or biostatistics preferred
    Experience Qualifications


    • 5 or More Years of relevant experience in the pharmaceutical industry required
    • Oncology experience preferred
    Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.

    Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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