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

Biostatistical Programming Senior Associate (POPPK/PD)

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