Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistical Programming Senior Associate in Hyderabad to perform statistical programming for clinical trials and regulatory submissions. The role involves analyzing complex clinical data, creating and validating datasets, and collaborating with global cross-functional teams on clinical development projects.
What they're looking for
- Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- Minimum 4 years statistical programming experience in clinical development environment
- Advanced SAS/STAT programming skills with proficiency in data manipulation and analysis
- Strong knowledge of CDISC SDTM, ADaM, and Define standards and their implementation
- Familiarity with drug development lifecycle, data quality tools, and compliance check processes
- Excellent English communication skills, both written and oral
- Ability to manage multiple projects across therapeutic areas in global team settings
What you'll be doing
- Analyze and report clinical trial data using SAS and/or R programming languages
- Create and validate complex SDTM, ADaM, and analysis datasets for safety and efficacy studies
- Generate and validate tables, listings, and figures; prepare statistical programming specifications
- Develop regulatory submission documentation and maintain tracking and validation records
- Collaborate across functions to develop and validate data quality and compliance check programs
Privacy & handoff
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