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    Opportunity: Director, Biostatistics -- Early Development @ Bristol-Myers Squibb -- Princeton, NJ (US)
    Submitted by Jody Aikawa; posted on Wednesday, November 06, 2013

    RESPONSIBILITIES

    The Therapeutic Area Lead (TAL) in Exploratory Development (ED) is a senior leader in GBS and serves as a member of the EDGBS Leadership Team. As such, the TAL has accountabilities to the sustained health, growth and continuous improvement of the GBS organization, inclusive of developing effective partnerships with critical stakeholders across R&D, particularly with the Early Clinical and Translational Sciences (ECTR) organization. Other key stakeholders include EDT Leads, Global Regulatory Science Leads, GBS VP, GBS TAHs, GBS Leads, GBS PBO and GBS Statistical Programming and Technologies groups. The TAL has direct accountability for the performance, scientific rigor, and timely contributions of the EDGBS under their direction.

    Primary Responsibilities:
    • Provides statistical and clinical trial expertise, and disease area and regulatory experience to the R&D organization, particularly the ECTR organization and the EDTs/Knowledge Integration Matrix teams.
    • Influences TA planning and decision-making strategy over a portfolio of early development compounds, through effective partnership with the GBS Planning and Business Operations group (PBO), senior leaders in DMCP, GRS, and GBS TAHs and Leads, especially in preparations for the transition to DP4.5.
    • Serves as a senior reviewer for project related documents.
    • May Represent GBS at End-of-Phase I and IIa meetings with the FDA and in interactions with other global regulatory agencies as needed.
    • Provides input and direction to EDGBS Statistical Leads on critical development issues, including data interpretation and preparing messages for senior management and on emerging scientific issues.
    • Contributes to the development of innovative processes and adoption of technologies that ensure the delivery of high quality and timely statistical analyses and data reporting.
    • Serves as a departmental representative on committees/initiatives within R&D with particular attention to GBS and DMCP initiatives, as needed.
    • Translates strategies into operational goals and objectives. Identifies necessary resources to accomplish goals and, in collaboration with the PBO, develops effective and strategic staffing solutions to manage resources, in accordance with R&D priorities/timelines/strategies, across multiple drug development programs.
    • Models scientific and functional leadership as well as core behaviors to EDGBS staff and other key stakeholders.
    • Recruits and retains high quality staff

    REQUIREMENTS

    • Ph.D. or equivalent in Biostatistics or related field with > 12 years experience in clinical research, preferably in the pharmaceutical industry.
    • Experience in managing GBS teams and developing biostatisticians
    • Demonstrated performance in scientific and strategic support of the drug development process leading to successful regulatory filings
    • Knowledgeable about strategic directions for the GBS organization across the pharmaceutical industry.
    • Experience interacting with senior level business partners and interacting with BMS governance bodies and external providers.
    • Strong communication/presentation skills with ability to tailor the message to key stakeholders for effective impact and influence.
    • Ability to be flexible and adapt quickly to the changing needs of the organization.
    • Ability to organize multiple work assignments and establish priorities.
    • Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
    • Demonstrated experience in planning and executing research activities in close collaboration with medical, clinical, regulatory and commercial partners.

    LOCALE

    Princeton, NJ

    HOW TO APPLY

    To apply for this position, copy/paste the following URL into your browser: ars2.equest.com/?res[...]85406

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