Biostatistical Programming Senior Associate
Amgen (company site, opens in a new tab)4+ yrsHyderabadOn-siteDirect career pageEst. 12–20 LPA
Posted on 1 Sept
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Job description
Structured overview of role & requirements
About This Role
- Perform hands-on statistical programming to support analysis and reporting of clinical trial data for regulatory submissions.
- Create, validate complex SDTM, ADaM datasets and tables/listings/figures for safety and efficacy.
- Collaborate globally with cross-functional teams and assist or back up the Study Lead Programmer.
Minimum Requirements
- Minimum 4 years statistical programming experience in clinical development environment.
- Degree in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific subject (BA/BSc or higher).
- Proficient with SAS/STAT packages and working knowledge of CDISC SDTM; familiarity with ADaM and Define standards.
- Work location: Hyderabad, India.
Ideal Candidate Profile
- Experienced in complex clinical trial data management and regulatory submission programming.
- Able to manage multiple projects across therapeutic areas within global, cross-cultural teams.
- Comfortable implementing CDISC standards and ensuring data quality and compliance.