Career CategoryClinicalJob DescriptionHOW 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.Biostatistics ManagerWhat you will doLet’s do this. Let’s change the world.Amgen is expanding its global Biostatistics capabilities, with Amgen India playing a key role in integrated delivery and functional leadership. As a Biostatistics Manager, you will provide technical expertise and support the execution of statistical deliverables for clinical studies. Operating under guidance, this role contributes through accurate implementation of statistical analytics within data visualization tools you create and ensures adherence to CfDA and regulatory standards.Responsibilities:Lead and oversee the application of biostatistical methods to analyze and interpret clinical trial data across multiple studies or programs, ensuring scientific rigor and consistencyProvide strategic direction and oversight for statistical programming using R and Python, enabling scalable, efficient, and compliant data analysis and reporting solutionsManage and review the development of tables, listings, and figures (TLFs), as well as outputs supporting clinical study reports, publications, and regulatory submissionsEnsure compliance with regulatory requirements, industry standards (including CDISC SDTM and ADaM), internal quality processes, and support audits and inspections as neededCollaborate with cross-functional teams to ensure timely delivery of study outputsIdentify, prioritize, and implement process improvements, tools, and innovative technologies to advance statistical programming and reporting capabilitiesStay current with emerging methodologies, technologies, and regulatory guidelines, and incorporate best practices into team workflowsProvide leadership, mentorship, and technical guidance to statisticians and programmers, fostering a culture of continuous improvement and excellenceAssist in developing and implementing AI-enabled technologies to streamline statistical workflows and build automated, reproducible reporting pipelines that enhance efficiency, quality, and traceabilityManage self and other resources according to prioritiesKnowledgeable of developments in the field of statistics in drug developmentContribute to the review and maintenance of Amgen policies, SOPs, and controlled documents to ensure ongoing compliance and alignment with regulatory standardsThis position is currently 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 strategic Biostatistics leader with a passion for tech-enabled transformation.Basic Qualifications:MSc or PhD in Statistics, Biostatistics, or related field.8 years relevant industry experienceProven ability to apply statistical methods in clinical development.Strong programming skills in R and/or PythonExperience with R Shiny or interactive reporting toolsPreferred Skills:Doctorate degree in Statistics/BiostatisticsExperience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applicationsLife-cycle drug development experienceExperience working effectively in a globally dispersed team environment with cross-cultural partnersExperience in the Obesity Therapeutic Area.