Director (Supervisory Mathematical Statistician)

Provides senior technical leadership and promotes innovative, science-based, quantitative decision-making throughout the total product life cycle. Oversees the division's review of critical materials submitted to or produced by CDRH including IDE, PMA, 510k applications. Establishes priorities for the division and ensures activities align with strategic priorities, mission, and Center goals. Directs statistical research and collaborations involving the design, analysis, and interpretation of laboratory studies, clinical trials, and observational studies. Conducts risk assessments and risk/benefit analyses for medical devices. Exercises the full range of first and second level supervisory responsibilities. Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work. Assigns work to subordinates based on priorities, considering the difficulty and requirements of assignments and the capabilities of employees.