**Biostatistical Programming Senior Associate** **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** **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 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 + 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 This position will be located at Amgen India (Hyderabad). **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation. Basic Qualifications: + BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment. + Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data + Ability to effectively perform complex statistical programming and related tasks + Ability to provide quality output and deliverables in adherence with challenging timelines + Ability to work effectively on multiple tasks or projects across therapeutic areas + Ability to work effectively and successfully in a globally dispersed team workplace with cross-cultural partners + Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards + In depth knowledge of SAS/STAT packages + Familiar with data quality and compliance check tools + Excellent oral and written English communication skills Preferred Skills: + MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects + Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming + Prior regulatory submission experience for drug approval

📌 Biostatistical Programming Senior Associate (Hyderabad)
🏢 AMGEN
📍 Hyderabad