Sr Director & Statistics Therapeutic Area Head, Oncology

About AbbVie
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, YouTube and LinkedIn.

The Senior Director, and Statistics Oncology TA Head leads all statistics activities related to oncology development and associated submissions. 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 Oncology TA Head partners with, clinical and regulatory experts to advance medicines to our patients.

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 spanning solid and hematologic malignancies.
• 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, optimal deployment/modification of disease response criteria and central imaging approaches.
• Content owner of TA specific data, analysis and reporting standards.

Qualifications

• MS/PhD in statistics or related field with 13+ years of experience in the pharmaceutical or biotechnology industry.
• Experience leading oncology programs through submission and approval.
• Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent.
• Demonstrated expertise in survival analysis and other advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification, precision medicine etc.).
• Understanding of oncology indications across solid and hematologic diseases including associated endpoints, response criteria and approval pathways.
• Excellent understanding of FDA/EMA guidance within the therapeutic area.
• 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

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.