Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistical Programming Senior Associate to perform statistical programming for clinical trials and regulatory submissions. This Hyderabad-based role involves analyzing trial data, creating and validating datasets, and collaborating with global cross-functional teams.
What they're looking for
- Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
- At least 4 years of statistical programming experience in clinical development
- Proficiency in SAS/STAT packages and familiarity with CDISC SDTM, ADaM, and Define standards
- Strong knowledge of drug development lifecycle and complex clinical trial data manipulation
- Experience with data quality and compliance check tools
- 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 SDTM, ADaM, and analysis datasets for safety and efficacy assessments
- Generate and validate complex tables, listings, and figures for regulatory submissions
- Prepare statistical programming specifications and regulatory submission documents
- Collaborate with cross-functional teams to develop data quality checks and support study leads
Privacy & handoff
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