Senior Director

7 days ago

South San Francisco, United States AbbVie Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

The Senior Director, Statistis leads all statistics activities related to development and associated submissions with this TA. This leader guides an organization of statisticians responsible for development/submission strategy and clinical trial methodology. A highly empowered, visible and collaborative role, the Statistics TA Head partners with, clinical and regulatory experts to advance medicines to our patients.

Responsibilities:

  • Set the vision for the statistics TA through building and maintaining a best-in-class organization. Maintain and establish (as needed) expertise in diseases within the TA.
  • Provide operational, strategic, and technical direction to product and project level statisticians with ultimate responsibility for all statistical deliverables within the TA.
  • Ensure the TA provides scientifically sound development strategies that incorporate both current best practices and innovative approaches. Propose and implement optimal methodologies including accelerated or seamless designs.
  • Support the development and validation of new clinical endpoints to support approval.
  • Maintain a strong external presence within the statistics community by representing abbvie on advanced and emerging topics. Attend key conferences and workshops in support of the presentation of company data, and the evaluation of scientific data presented across industry and academia.
  • Represent abbvie at key regulatory meetings and/or FDA advisory committee meetings or deploy qualified staff as appropriate.
  • Serve in the Data and Statistical Sciences Senior Leadership Team to provide guidance on direction and operations of the department as a whole, and to protect and preserve the abbvie culture.
  • Ensure proper precision medicine strategies and methods.
    Content owner of TA specific data, analysis and reporting standards.
    Qualifications

    Qualifications:

    • PhD in statistics or related field with 13+ years (or MS with 18+ years) of experience in the pharmaceutical or biotechnology industry.
    • Solid Tumor experience highly preferred.
    • Experience leading Oncology development programs through submission and approval. Previous experience within the TA is required.
    • Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent.
    • Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification, precision medicine etc.).
      Excellent understanding of FDA/EMA guidance within the TA.
    • Ability to communicate with clarity and influence to executives, regulators and key stakeholders.
      Experienced negotiator with excellent judgment around compromising, standing firm, or finding a new way forward.
      Leadership acumen including emotional intelligence and business awareness. Ability to effectively collaborate and influence throughout multiple levels of the organization.
    • Demonstrated external presence via activities within the statistical/drug development community and publication record.

      Key Stakeholders

      Clinical Development TA Heads
      Regulatory Affairs TA leadership
      Additional Information

      Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

      • The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

      • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

      • This job is eligible to participate in our short-term incentiveprograms.

      • This job is eligible to participate in our long-term incentiveprograms

        Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

        AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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