Senior Manager, Biostatistical Programming
Amgen · Hyderabad, India
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Role summary
Senior Manager leading offshore biostatistical programming teams in Hyderabad to deliver clinical trial analyses and regulatory submissions across product portfolios. Requires 8+ years of statistical programming experience in clinical development, strong technical leadership abilities, and experience building offshore programming capabilities. Responsible for strategy implementation, resource management, team mentoring, and cross-functional process improvements.
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 managing offshore statistical programming teams
- Strong leadership, communication, and project management capabilities
- Proficiency in data quality checks, compliance standards, and software development practices
What you'll be doing
- Oversee end-to-end programming execution and delivery of statistical analysis milestones
- Lead offshore Study Programmer team to ensure successful project completion across products
- Partner with Global Programming Lead on strategy implementation and regulatory submissions
- Monitor project progress, manage resources and budgets, address issues at product level
- Mentor and develop programming staff; provide coaching on technical and career growth matters
Privacy & handoff
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