Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
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Role summary
This role involves performing statistical programming activities to support clinical trial data analysis and regulatory submissions. The Senior Associate will create and validate complex datasets, tables, and figures using SAS and R, prepare programming specifications, and collaborate with global cross-functional teams. The position requires a quantitative degree with at least 4 years of clinical programming experience and strong expertise in CDISC standards.
What they're looking for
- BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- At least 4 years of statistical programming experience in clinical development
- Deep expertise with SAS/STAT packages and complex clinical trial data manipulation
- Working knowledge of CDISC SDTM, ADaM, and Define standards
- Familiarity with data quality and compliance check tools
- Excellent written and oral English communication skills
- Ability to manage multiple projects across therapeutic areas
What you'll be doing
- Perform statistical programming analysis and reporting of clinical trial data using SAS and/or R
- Create and validate complex SDTM, ADaM, and analysis datasets for safety and efficacy
- Generate and validate tables, listings, and figures supporting clinical submissions
- Prepare statistical programming specifications and regulatory submission documents
- Collaborate with cross-functional global teams on data quality programs and validation
Privacy & handoff
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