Senior Manager, Biostatistical Programming

Lead and manage an offshore statistical programming team for successful delivery of programming milestones and regulatory submission packages across one or more product areas.

Collaborate with Global Programming Lead to implement global programming strategies, manage resource plans, budgets, and oversee progress and issue resolution for programming projects.

Drive process improvements, oversee compliance audits, develop and enforce global policies/SOPs, provide coaching and career development for programming staff.

Bachelor’s degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.

Minimum 8 years of statistical programming experience in clinical development environment.

Strong expertise in SAS programming including advanced analysis and reporting (SAS/STAT, Macro, Graph, SQL).

Experience leading offshore programming teams and working with regulatory submission activities for drug approval.

Experienced leader capable of managing globally dispersed, cross-cultural teams and delivering end-to-end programming for clinical studies.

Technically adept with strong knowledge of clinical trial operations, data quality, compliance, and software development lifecycle.

Skilled at developing staff, managing budgets, and facilitating cross-functional collaboration and process improvements.