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Senior Director & Statistics Therapeutic Area Head - Eye Care

Employer
AbbVie
Location
Irvine, California
Start date
Feb 14, 2024

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Job Details

The Senior Director, and Statistics Therapeutic Area Head for Eye Care 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. In a highly empowered, visible and collaborative role, the Statistics TA Head partners with clinical and regulatory experts to advance medicines to our patients.

Major Job 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 AbbvVie 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.


  • PhD in statistics or related field with 13+ years (or MS with 18+ years) of experience in the pharmaceutical or biotechnology industry.
  • Experience leading development programs through submission and approval. Previous experience within the TA or demonstration of proficiency in navigating new disease areas 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

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

·      The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

·      We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

·      This job is eligible to participate in our short-term incentive programs. 

·      This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s 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.


Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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