Director, Statistical Programming, Clinical Schedules (Hybrid)

Role: Lead the Clinical Schedule Management team within BARDS, overseeing development and review of randomization and unblinding schedules for early and late-phase drug and vaccine trials. Responsibilities include setting strategic direction across therapeutic areas, managing staff and resource forecasting, ensuring compliance with SOPs and regulatory standards, and collaborating with cross-functional teams such as Statistics, Data Management, IT, and Clinical Supply. The role involves stakeholder engagement, process improvement, and representing the function at leadership levels. Requirements: Bachelor's or Master's in relevant fields (e.g., Statistics, Biological Sciences), with at least 10-12 years in analysis/reporting environments, including 2+ years of people management and project management experience in clinical trials. Expertise in randomization, clinical schedule specifications, and regulatory submissions is essential. Preferred skills include team leadership for 3+ years, change management, strategic planning, and process improvements. High-value biopharma specifics: focus on clinical schedule management for drug and vaccine programs, with experience across early and late-phase development, regulatory interactions, and global clinical trial operations. Work setup: hybrid, with 10% travel, based in Rahway, NJ or Upper Gwynedd, PA.