Biostatistical Programming Senior Associate (POPPK/PD)
Amgen (company site, opens in a new tab)4+ yrsHyderabadOn-siteDirect career pageEst. 12–20 LPA
Posted 18d ago
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Job description
Structured overview of role & requirements
About This Role
- Perform hands-on statistical programming for clinical trial analysis and regulatory submissions using SAS and/or R.
- Create, validate, and manage complex SDTM, ADaM datasets and related tables, listings, and figures for safety and efficacy data.
- Support Population PK/PD dataset creation and lead or back up small projects in this area, ensuring timely delivery of high-quality outputs.
Minimum Requirements
- Bachelor’s degree (BA/BSc) or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
- At least 4 years of statistical programming experience in clinical development environment.
- Working knowledge of CDISC SDTM standards and familiarity with CDISC ADaM and Define standards.
- Proficiency in SAS/STAT packages and ability to handle complex clinical trial data for regulatory submissions.
Ideal Candidate Profile
- Experienced in global collaboration and managing multiple projects across therapeutic areas with adherence to timelines.
- Capable of leading small teams and providing technical guidance, especially in Population PK/PD dataset programming.
- Familiar with pharmacokinetic/pharmacodynamic data and the drug development life cycle, with prior regulatory submission exposure.