Associate Director, Statistics
3 weeks ago
*This position will sit on-site 3 days/week*
Purpose:
The Associate Director in Statistical Innovation is responsible for providing scientific and statistical leadership to lead or collaborate with other functions on important clinical development and DSS initiatives and projects, especially those using advanced statistical methodology, advanced predictive modeling and ML/DL.
Key Responsibilities:
Lead cutting edge methodology identification, investigation, implementation and simulation activities to support Calico program
Lead or support safety related analyses, modeling and interpretation for Calico program
Lead or collaborate with other functions on important global therapeutics or DSS innovation initiatives using advanced statistical methodology, advanced predictive modeling and/or ML/DL.
Lead or co-lead high priority statistical excellence working group(s) that investigate novel methodologies and provide technical reports and guidance/best practice documents and applications to DSS statisticians
Provide strategic and technical input to clinical development programs on innovative approaches to increase efficiency
Provide strategic consulting and simulation support to DSS internal or external partners on innovation related projects
Propose and drive opportunities to participate in the complex innovative design (CID) initiative from FDA
Stay on top of advanced and emerging statistical methodologies including adaptive designs, AI/ML, imaging deep learning, generative AI, synthetic control and digital twin, and provide education seminars to DSS internal and external partners
Builds and maintains external reputation and influences in the industry with presentations, by attending industry meetings, and authoring peer-reviewed publications
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
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