Director, Statistical Programming, Clinical Schedules (Hybrid)

Director-level statistical programming leader in biostatistics overseeing clinical schedule management activities for drug and vaccine development programs. Responsible for directing team operations, ensuring quality and compliance across early and late-phase trials, and managing cross-functional partnerships to advance clinical trial capabilities.

Responsibilities

• Direct clinical schedule managers developing randomization schedules and associated specifications across early and late phase programs
• Set direction for clinical schedule management strategy across therapeutic areas ensuring efficient, timely execution with high quality
• Manage staff resources, forecast support needs, and oversee hiring and performance development of team members
• Partner with Statistics, Data Management, IT, and Clinical Supply teams to enhance schedule management and unblinding capabilities
• Lead strategic departmental initiatives and represent clinical schedule management at organizational leadership level

Requirements

• Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering; Master's preferred
• 12+ years in analysis/reporting environment (BS) or 10+ years (MS)
• 2 years statistical programming experience in clinical trials
• 1 year leading and managing a team
• 7 years project management in statistical analysis and reporting deliverables
• Expertise in randomization, clinical schedule specification, and regulatory submissions at leadership level
• Strong knowledge of clinical blinding, study design complexities, and regulatory agency requirements