Career CategoryResearchJob DescriptionAmgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing an increasingly critical role in integrated delivery and functional leadership. As Senior Manager, Biomedical Data Stewardship, you will help advance Amgen’s analysis and reporting standards by leading India-based execution while partnering closely with global BMDS and cross-functional teams.You will manage and develop BMDS staff and managing resources, as well as oversee the development, governance, and consistent implementation of analysis and reporting data standards, including ADaM, in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands- on technical depth, managerial accountability, and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy.Responsibilities:This role supports global Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration.Collaborate with global BMDS leadership and cross-functional partners to ensure alignment with enterprise standards strategy.Support development and maintenance of data element standards (DES) with a focus on analysis and reporting standards including Analysis Data Model (ADaM)Provide subject-matter leadership and input into the strategic adoption and implementation of Clinical Data Interchange Standards Consortium (CDISC) standards and regulatory guidance documentsStay abreast of latest developments and requirements in the field of analysis and reporting standards, CDISC, and regulatory guidance/practiceSupport process improvement initiatives related to the governance of standardsEnsure changes to standards are implemented consistently and in a timely mannerManage and develop Biomedical Data Stewardship staff and managing resourcesSupport development and delivery of training, awareness presentations, and/or communications about standardsProvide DES expertise to stakeholders across R&D ensuring alignment across functionsDevelop and maintain strong working relationships with key stakeholdersIdentify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation.Adhere to all Amgen Policies, SOPs and other controlled documents when developing, maintaining, and governing data standardsThis position is currently located at Amgen India (Hyderabad).Basic QualificationsBachelor’s degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline, or equivalent combination of education and experience6+ years knowledge/experience in biostatistics or programming in the Pharmaceutical/Biotech industry4+ years of CDISC ADaM implementationPeople management, including direct reportsPreferred QualificationsMaster’s degree or higher in statistics/biostatistics, programming, life science, computer science, business administration, or related discipline4+ years of experience in a global organizationTeam and process improvement leadershipDemonstrated effective communication skills (written and oral)Data Standards & Technical ExpertiseExperience defining, managing, and governing analysis and reporting standards with a focus on ADaM data standards; aptitude for data standards and data standardizationExperience implementing SDTM and ADaM standards in a practical setting across multiple study designsStatistical Programming skill for SDTM and ADaMExperience creating SDTM and ADaM submission packagesIn-depth knowledge of CDISC standardsCollaboration & CommunicationExperience working in collaboration with global cross-functional teams with demonstrated effective communication skills (written and oral) and ability to influence decision makingKnowledge of project management, documentation writing, training, and complianceProcess & GovernanceUnderstanding of CDISC Therapeutic Area User Guides (TAUGs)Experience developing and maintaining standards implementation guidesWhat 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 develop within 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.