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. • Adhere to Amgen policies, SOPs, and other controlled documents. Key Skills / Knowledge: Data Standards & Technical Leadership • Broad working knowledge of clinical data standards across protocol, data collection, SDTM, ADaM, controlled terminology, metadata, and submission data lineage. • Experience leading implementation and governance of standards in a regulated clinical development setting. • Ability to evaluate specialist recommendations, balance cross-domain impacts, and delegate detailed technical development. • Understanding of CDISC standards, regulatory expectations, and the end-to-end drug development process. Collaboration & Communication • Demonstrated leadership of direct reports and multidisciplinary teams, including coaching, performance management, and resource prioritization. • Ability to influence department leads, facilitate agreement across functions, and communicate complex standards issues to technical and nontechnical audiences. • Experience working across global teams and building productive relationships with clinical data management, programming, biostatistics, and regulatory writing partners. Process & Governance • Experience with governance committees, standards lifecycle management, decision records, impact assessment, change control, and implementation planning. • Ability to use metrics, risk assessment, and process improvement to improve standards adoption, quality, and compliance. • Experience contributing to policies, SOPs, training, audits, and inspection-ready documentation. Qualifications: Basic Qualifications • Bachelor's degree or higher in computer science, statistics, mathematics, life sciences, or a related discipline, or equivalent combination of education and experience. • 10+ years of experience in the pharmaceutical or biotechnology industry. • 5+ years of experience leading implementation of clinical data standards in a regulated environment. • Experience managing direct reports and leading cross-functional standards work. Preferred Qualifications • Master's degree or higher in a relevant scientific or technical discipline. • Experience across data collection, submission data, analysis and reporting, and metadata or repository governance. • Experience with regulatory submissions using CDISC standards and with standards-related inspection readiness. • Budget, resource, and project planning experience in a global clinical development organization. • Leadership of process improvement, controlled document development, and standards governance forums. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Associate Director, Biomedical Data Stewardship (Standards Lead).

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