Website AbbVie
AbbVie
Company : AbbVie
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.