Biostatistical Programming Senior Associate (POPPK/PD) in Hyderabad, भारत

Amgen seeks a Biostatistical Programming Senior Associate to perform statistical programming for complex clinical trial data analysis and regulatory submissions. The role is based in Hyderabad and supports integrated delivery across regions, with potential focus on Population PK/PD dataset creation.

Responsibilities

• Perform hands-on statistical programming using SAS and/or R for clinical trial data analysis
• Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy outcomes
• Generate and validate complex tables, listings, and figures; prepare statistical programming specifications
• Prepare regulatory submission documents and maintain tracking and validation documentation
• For PopPK/PD assignments: create input datasets for NONMEM software and serve as backup lead on projects

Requirements

• BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
• Minimum 4 years statistical programming experience in clinical development environment
• In-depth knowledge of SAS/STAT packages and working knowledge of CDISC SDTM, ADaM, and Define standards
• Strong proficiency in complex clinical trial data manipulation, analysis, and reporting
• Ability to manage multiple projects across therapeutic areas in globally dispersed teams
• Familiarity with data quality and compliance check tools; excellent English communication skills
• For PopPK/PD assignments: experience with phase 1-3 studies and pharmacokinetic/pharmacodynamic data