Biostatistical Programming Senior Associate
Amgen · Hyderabad, India
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Role summary
This role focuses on managing randomization and blinding processes for clinical trials within Amgen's Global Randomization and Blinding organization. The Senior Associate will develop randomization lists, write and validate SAS programs to verify assignments, manage Interactive Response Technology data transfers, and maintain documentation and compliance with study procedures throughout the trial lifecycle.
What they're looking for
- Bachelor's degree in biostatistics, statistics, mathematics, computer science, or related field
- At least four years of statistical programming experience in clinical development
- Proficiency in SAS version 8.2 or higher, or R/Python
- Understanding of drug development processes and operations
- Knowledge of computer operating systems, including UNIX preferred
- Basic understanding of Interactive Response Technology systems preferred
What you'll be doing
- Create and deliver participant and investigational product randomization lists per specifications
- Write and validate SAS programs to verify randomization assignments and dose decisions
- Manage Interactive Response Technology data transfer activities as study programmer
- Serve as gatekeeper for IRT data transfers into secure File Transfer Protocol locations
- Ensure study blind procedures are maintained throughout trial lifecycle per operating procedures
Privacy & handoff
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