Biostatistical Programming Mgr
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistical Programming Manager to lead statistical programming teams and serve as Study Lead Programmer for clinical trials in Hyderabad. The role involves managing end-to-end study programming strategy, team oversight, regulatory submissions support, and hands-on SAS programming within a global clinical development environment.
What they're looking for
- Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- Minimum 6 years statistical programming experience in clinical development
- Proven team leadership managing statistical programmers through study completion
- Advanced SAS proficiency including SAS/STAT packages and reporting capabilities
- In-depth knowledge of CDISC SDTM, ADaM, and Define standards
- Strong project management skills and excellent English communication abilities
- Experience with data quality and compliance check tools
What you'll be doing
- Lead one or more clinical studies end-to-end as Study Lead Programmer with full accountability
- Establish programming strategy, timelines, quality standards, and compliance for all deliverables
- Create and maintain SDTM and ADaM specifications with statisticians and study teams
- Manage statistical programmer assignments and provide technical leadership and guidance
- Represent programming function in cross-functional study meetings and coordinate data issue resolution
Privacy & handoff
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