Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistical Programming Senior Associate to support clinical trial data analysis and regulatory submissions. The role involves statistical programming in SAS/R, dataset creation and validation, and collaboration with global cross-functional teams in Hyderabad, India.
What they're looking for
- Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- Minimum 4 years of statistical programming experience in clinical development
- Proficiency with SAS/STAT packages and knowledge of CDISC SDTM, ADaM, and Define standards
- Strong ability to manipulate, analyze, and report complex clinical trial data
- Experience with data quality and compliance check tools
- Fluent written and oral English communication skills
- Ability to manage multiple projects across therapeutic areas in a global environment
What you'll be doing
- Analyze and report clinical trial data using SAS and/or R programming
- Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy studies
- Generate and validate complex tables, listings, and figures for regulatory reporting
- Prepare statistical programming specifications and regulatory submission documents
- Support Study Lead Programmer tasks and serve as backup programmer as needed
Privacy & handoff
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