**Biostatistical Programming Senior Associate (** **_POPPK/PD)_** **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 **_For those assigned to the creation of Population PK and Population PK/PD datasets,



key responsibilities may also include but not limited to:_** + Create input datasets (ADPPK/PopPK, ADPKPD/PopPKPD, and ERPK) for NONMEM® software to support Population PK and Population PK/PD analyses conducted by the Clinical Pharmacology Modelling and Simulation (CPMS) team. + Create and review of PKPD and ERPK specification mappings. + Serve as the backup Lead and support for at least one PopPK/PD project at a time. + Manage individual programming assignments to ensure timely delivery of high-quality datasets and outputs. **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 skilled 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 environment 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 _If assignment includes the creation of Population PK and Population PK/PD datasets:_ + Ability to lead small team projects effectively, willingness and ability to provide guidance to team members on technical and process questions + Experience working with phase 1, 2, and 3 studies + Familiarity with pharmacokinetic and pharmacodynamics data 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 **_If assignment includes the creation of Population PK and Population PK/PD datasets:_** + Experience developing specifications for other programmers + Experience in understanding PK data workflow. **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, so we work to care for our teammates' qualified and personal growth and well-being. + Vast opportunities to learn and move up and across our global organization + Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act + Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

📌 Biostatistical Programming Senior Associate (POPPK/PD) (Hyderabad)
🏢 AMGEN
📍 Hyderabad