Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
BiometricsFull-timeCompany career page
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Role summary
Amgen seeks a Biostatistical Programming Senior Associate to perform statistical programming for clinical trials and regulatory submissions. The role involves complex data analysis, dataset creation, and cross-functional collaboration in support of integrated delivery across regions.
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
- 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 check tools
- Excellent English communication skills, both oral and written
- Experience working in globally dispersed, cross-functional team environments
What you'll be doing
- Analyze and report clinical trial data using SAS and/or R programming
- Create and validate complex SDTM, ADaM, and analysis datasets for safety and efficacy
- Develop and validate tables, listings, and figures for regulatory submissions
- Prepare statistical programming specifications and regulatory documentation
- Support Study Lead Programmer tasks and serve as backup when needed
Privacy & handoff
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