Senior Manager, Biostatistical Programming

$167.6k - $251.39k

Amgen Inc

AstraZeneca seeks a Director-level Product Quality Leader to oversee end-to-end quality strategy and lifecycle management for autologous, allogeneic, and in-vivo cell therapy products. The role involves technical and compliance oversight across clinical and commercial stages, with responsibility for advanced modalities including viral delivery systems and gene-edited therapies.

Responsibilities

Ensure successful execution and delivery of programming milestone analyses and regulatory submission packages
Implement programming strategies and functional standards globally with Global Programming Lead
Plan, monitor, and manage project progress for assigned product areas
Lead offshore team of Study Lead Programmers and Study Programmers on end-to-end programming activities
Provide coaching, mentoring, and career development support to local programming staff

Requirements

BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
Minimum 8 years statistical programming experience in clinical development
Advanced SAS proficiency including STAT, Macro, Graph, SQL modules
Prior regulatory submission experience for drug approval processes
Experience developing and leading offshore statistical programming teams
Software development experience including requirements gathering and test planning
Strong technical, communication, and leadership capabilities

Apply

Vacancy posted 7 days ago

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