Senior Manager, Biostatistical Programming
Amgen
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
Vacancy posted 9 days ago
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