Amgen—Biostatistical Programming Senior Associate (POPPK/PD)

Job description

Description: Career Category Clinical Job Description 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 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 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’ professional 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 .