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    Associate Director Biostatistics - New Jersey, United States - Daiichi Sankyo, Inc.

    Daiichi Sankyo, Inc.
    Daiichi Sankyo, Inc. New Jersey, United States

    3 weeks ago

    Daiichi Sankyo, Inc. background
    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 16,000 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.

    Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

    This position supports early phase oncology development and 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.

    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. collaborates closely with data manager to ensure high quality data.

    • 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 prespecified product profile.
    • 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. 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. PhD in statistics or biostatistics preferred Experience Qualifications
    • 8+ Years of relevant experience in the pharmaceutical industry with a masters degree required
    • 5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel Ability to travel up to 10%

    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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