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 from its Hyderabad office. The role involves creating and validating complex datasets, tables, and figures using SAS and R, preparing programming specifications, and collaborating across global teams. Candidates need a quantitative degree with at least 4 years of clinical programming experience and expertise in CDISC standards.
What they're looking for
- Bachelor's degree in biostatistics, statistics, mathematics, computer science, or related quantitative field
- At least 4 years of statistical programming experience in clinical development
- Advanced proficiency with SAS/STAT packages and complex data manipulation
- Working knowledge of CDISC SDTM, ADaM, and Define standards
- Familiarity with data quality and compliance checking tools
- Excellent written and oral English communication skills
- Experience working across multiple therapeutic areas and distributed global teams
What you'll be doing
- Perform statistical programming activities to support clinical trial data analysis and regulatory submissions
- Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy studies
- Generate and validate tables, listings, and figures for clinical trial reporting
- Develop statistical programming specifications and regulatory submission documents
- Collaborate with cross-functional study teams to implement data quality checks and validation programs
Privacy & handoff
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