Biostatistical Programming Manager
Amgen
Amgen seeks a Biostatistical Programming Manager to lead statistical programming teams and serve as Study Lead Programmer for clinical trials in Hyderabad, India. The role involves managing end-to-end study programming, establishing standards and timelines, and supporting regulatory submissions across integrated analyses.
Responsibilities
- Lead one or more studies end-to-end as Study Lead Programmer with full accountability
- Set programming strategy, establish timelines, and ensure quality and compliance of deliverables
- Create and maintain SDTM, ADaM, and programming specifications for studies
- Perform hands-on statistical programming for challenging deliverables and mentor team members
- Represent Global Statistical Programming at Clinical Study Team meetings and cross-functional activities
Requirements
- 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 expertise
- Advanced SAS proficiency including SAS/STAT packages and data quality tools
- Proven ability to lead and manage statistical programmers on study-level projects
- Excellent project management and cross-cultural communication skills
- Thorough understanding of clinical trial processes from data collection to reporting
Vacancy posted 8 days ago
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