Biostatistical Programming Senior Associate (Innovation)

Career Category Clinical Job Description Biostatistical Programming Senior Associate (Innovation) HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Biostatistical Programming Senior Associate (Innovation) NOTE: THIS ROLE DIFFERS FROM A TRADITIONAL STATISTICAL PROGRAMMING POSITION. What you will do Let’s do this. Let’s change the world. Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will focus on developing programming efficiencies, automation solutions, and innovative tools that enhance productivity and scalability across programming teams. This position is ideal for candidates who enjoy building systems and optimizing workflows—not for those primarily seeking to perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.  Key Responsibilities: Analysis and reporting of clinical trial data using SAS and/or R or Python Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy Creation and validation of complex tables, listings, and figures, both safety and efficacy Prepare statistical programming specifications Prepare statistical programming related documents for regulatory submissions Maintain tracking and validation documentation Collaborate with cross-functional team and create and/or validate complex programs for checking data quality Interact and collaborate with study team members from other functions globally Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP Design, build, and maintain programming solutions and tools that improve efficiency and quality across statistical programming ecosystems. Contribute to the full development lifecycle—from requirements gathering and design through testing, deployment, and maintenance. Collaborate with programming teams across center for design and analysis (CfDA) to identify process gaps and prototype scalable solutions using modern programming practices. Support federated innovation—integrating ideas and code contributions from other programming teams into unified, CfDA-wide solutions. Automate repeatable programming tasks and establish standards for modular, reusable code. Leverage AI and machine learning capabilities, including developing and deploying AI agents or copilots, to optimize programming workflows and knowledge sharing.