Senior Manager, Biostatistical Programming
Amgen · Santa Monica Colorado Avenue, CA
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Role summary
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.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-29). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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