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    Director /Sr. Director Biostatistics

    REQ-10060726
    9月 08, 2025
    USA

    摘要

    As the Director/Sr Biostatistics, you will influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) across multiple indications/ therapeutic/ disease areas within drug development. You will lead and integrate input from different quantitative scientists impacting clinical development, health authority interactions, represent the Advanced Quantitative Sciences function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.

    About the Role

    Key Responsibilities:

    • Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program
    • Strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
    • Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans
    • Collaborate across functions to ensure timeliness and quality of statistical deliverables
    • Propose and implement innovative designs and methods to optimize drug development.
    • Represent all functions within Advance Quantitative Sciences (Biostatistics, Pharmacometrics, Statistical Programming) at project meetings
    • Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.
    • Lead the review and implementation of health authority guidance.
    • Represent biostatistics in interacting with external experts (statistical, clinical, and technical).

    Essential Requirements:

    • MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience
    • Has advanced knowledge of applying statistics and innovative approaches
    • Expert knowledge in a variety of statistical areas
    • Experience in outcome trials
    • Record of successful implementation of novel methods and/or innovative strategies in drug development
    • Extensive knowledge of drug development and HA guidelines
    • Strong understating of at least one disease area
    • Fluent English (oral and written)
    • Strong interpersonal and communication skills bridging scientific and business needs

    Desirable Requirements:

    • Proven people leadership ability and expert skills in building partnerships and collaborations.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

    Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

    Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

    Development
    Universal Hierarchy Node
    USA
    New Jersey
    East Hanover
    Research & Development
    Full time
    Regular
    No
    A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
    REQ-10060726

    Director /Sr. Director Biostatistics

    Apply to Job

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    5. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/East-Hanover/Director--Sr-Director-Biostatistics_REQ-10060726
    6. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/East-Hanover/Director--Sr-Director-Biostatistics_REQ-10060726