Biostatistical Programming Senior Associate

Career CategoryEngineeringJob DescriptionBiostatistical 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 AssociateWhat you will doLet’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 RCreation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacyCreation and validation of complex tables, listings, and figures, both safety and efficacyPrepare statistical programming specificationsPrepare statistical programming related documents for regulatory submissionsMaintain tracking and validation documentationCollaborate with cross-functional team and create and/or validate complex programs for checking data qualityInteract and collaborate with study team members from other functions globallyAssist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLPThis position will be located at Amgen India (Hyderabad).WinWhat we expect of youWe 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 dataAbility to effectively perform complex statistical programming and related tasksAbility to provide quality output and deliverables in adherence with challenging timelinesAbility to work effectively on multiple tasks or projects across therapeutic areasAbility to work effectively and successfully in a globally dispersed team environment with cross-cultural partnersWorking knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standardsIn depth knowledge of SAS/STAT packagesFamiliar with data quality and compliance check toolsExcellent oral and written English communication skillsPreferred Skills:MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjectsFamiliarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programmingPrior regulatory submission experience for drug approvalThriveWhat you can expect of usAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.