Biostatistical Programming Manager
Amgen · Hyderabad, India
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Role summary
Amgen seeks an experienced biostatistical programming manager to lead clinical trial programming activities in Hyderabad. The role involves managing statistical programmer teams, establishing programming strategies, ensuring regulatory compliance, and delivering high-quality study data specifications for integrated analyses.
What they're looking for
- BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- Minimum 6 years statistical programming experience in clinical development
- Deep knowledge of CDISC SDTM, ADaM, and Define standards with implementation ability
- Advanced SAS expertise including SAS/STAT packages and data quality tools
- Proven leadership experience managing statistical programmers and multiple projects
- Strong project management and cross-cultural collaboration skills
- Excellent English communication skills, both written and oral
What you'll be doing
- Lead one or more clinical studies end-to-end as Study Lead Programmer with full responsibility
- Establish programming strategy, timelines, quality standards, and regulatory compliance for deliverables
- Direct programming team assignments and perform hands-on statistical programming on complex deliverables
- Create and maintain SDTM, ADaM, and programming specifications; represent GSP at clinical study teams
- Coordinate data quality reporting, cross-functional meetings, and provide technical guidance to programming staff
Privacy & handoff
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