Associate Director, Biomedical Data Stewardship (Standards Lead)

Career Category Research Job Description Amgen is expanding its global Biomedical Data Stewardship (BMDS) capabilities, with Amgen India (AIN) playing a key role in integrated delivery. As Associate Director and Standards Lead, you will lead the India-based BMDS standards team and advance consistent clinical data standards across the development lifecycle. You will translate global BMDS strategy into team priorities, manage standards specialists, and serve as a senior point of contact for Clinical Data Management, Global Statistical Programming, Global Biostatistics, and Global Regulatory Writing. The role calls for broad judgment across standards domains and the ability to bring together specialist expertise in support of Design & Innovation within the Center for Design & Analysis. Key Responsibilities: •       Lead the India-based BMDS standards team, including direct reports; set goals, prioritize work, allocate capacity, recruit, coach, assess performance, and develop staff. •       Translate the global BMDS standards strategy into an India delivery plan spanning protocol and data collection, submission data, analysis and reporting, controlled terminology, and metadata. •       Act as the senior BMDS liaison with Clinical Data Management, Global Statistical Programming, Global Biostatistics, and Global Regulatory Writing leads; resolve dependencies and align priorities. •       Lead or co-lead data standards governance forums within delegated scope; evaluate proposals, document decisions, and escalate matters requiring global BMDS or cross-functional agreement. •       Oversee specialists who develop, maintain, and implement standards; ensure technical quality, version control, data lineage, change impact assessment, and consistent adoption. •       Guide alignment of standards from protocol through collection, SDTM, ADaM, metadata repositories, and regulatory submission deliverables, drawing on domain experts for detailed decisions. •       Assess emerging industry standards and regulatory guidance with subject matter experts, and recommend adoption plans and risk controls. •       Establish measures for standards adoption, exceptions, quality, and delivery; report progress and risks to global BMDS and Design & Innovation leadership. •       Sponsor improvements to governance processes, metadata tools, and automation; develop proposals for technical solutions and related resources. •       Partner with functional leads on implementation plans, communications, training, and transition of approved standards into studies and programs. •       Lead or contribute to policies, SOPs, implementation guides, and controlled documents; support audits and inspection readiness related to standards. •       Contribute to resource and budget planning, vendor needs, and prioritization across India and global BMDS work. •       Represent BMDS in relevant external standards forums when appropriate, and maintain strong relationships across R&D.