The Senior Director & Statistics Therapeutic Area (TA) Head (Immunology) leads all statistics activities related to development and associated submissions within the Immunology 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.
Major Job Responsibilities:
Set the vision for the Immunology statistics TA through building and maintaining a best-in-class organization. Maintain and establish (as needed) expertise in diseases within the Immunology TA.
Provide operational, strategic, and technical direction to product and project level statisticians with ultimate responsibility for all statistical deliverables within the Immunology TA.
Ensure the Immunology 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 Immunology TA specific data, analysis and reporting standards.
Level will be based on education & years of experience.
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 Immunology 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 Immunology 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.
AbbVie is an Equal Employment Opportunity employer: 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.
Significant Work Activities and Conditions: N/A
Job Type: Experienced