Data Standards & Metadata Governance Lead

Amgen 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 Data Element Standards (DES) and support Precision Medicine and Clinical Data Hub (CDH) needs through India-based execution while partnering closely with global BMDS and cross-functional teams.

You will act in support of the Design & Innovation function within the Center for Design & Analysis. This position combines hands-on technical depth and cross-functional collaboration to ensure data standards are fit-for-purpose, inspection-ready, and aligned with Amgen’s global clinical development strategy.

• →This role supports global Precision Medicine and Biomedical Data Stewardship objectives through India-based execution and cross-functional collaboration.
• →Collaborate with fellow Clinical Data Hub (CDH) cross-functional partners and global BMDS leadership to ensure alignment with enterprise standards strategy.
• →Provide subject matter expertise to improve the clinical data and analytics ecosystem to enable precision medicine. 
• →Support developing clinical trials by making data more accessible, interoperable, usable and scalable, through SDTM, ADaM, and developing and maintaining a Metadata Repository (MDR).
• →Support MDR entry across multiple functional areas.
• →Validate MDR entry success through output review; diagnose and remediate when deviations from Global or Product Standards occur.
• →Support the development and maintenance of MDR QC reports as they relate to Precision Medicine and CDH to monitor data entry quality and output success.
• →Provide DES expertise to stakeholders across R&D ensuring alignment across functions.
• →Develop and maintain strong working relationships with key stakeholders.
• →Identify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation within protocol authoring governance.
• →Adhere to all Amgen Policies, SOPs and other controlled documents when developing, maintaining, and governing data standards.

• In depth knowledge of, and experience working with, CDISC Standards including SDTM and ADaM
• In depth knowledge of, and experience working with Controlled Terminology ensuring data lineage and regulatory compliance
• Experience defining, managing, and governing data standards; aptitude for data standards and data standardization with specialized experience in managing version control
• Experience with data modelling and database design
• Experience in executing rigorous quality control on high-volume datasets of controlled terminology, identifying anomalies and with bulk validation
• MDR experience is not necessary but must have a willingness to learn the MDR and underlying data tables.

• Experience working in collaboration with global cross-functional teams with demonstrated effective communication skills (written and oral) and ability to influence decision making
• Experience developing documentation writing, training, and compliance
   

• Working knowledge of regulatory requirements and inspection readiness expectations.
• Knowledge of standards governance processes including versioning, impact analysis, documentation, approval workflows, and audit readiness.
• Understanding of the end-to-end drug development lifecycle and global regulatory expectations, including the necessity of standards.

• Bachelor’s degree or higher in computer science with 12 - 17 yrs professional experience statistics/biostatistics, programming, life science, business administration, or related discipline, or equivalent combination of education and experience.

• Master’s degree or higher in computer science, statistics/biostatistics, programming, life science, or related discipline
• 2+ years experience leading MDR implementation and application of standards in a regulated Clinical Development setting
• Drug Development experience (pre-, early, late phase and/or observational studies) in related industries or academic research
• Experience supporting cross-functional initiatives
• Project planning and management experience
• Process improvement and operational effectiveness leadership
• Development of policies and SOPs
• External visibility (industry committees/forums)
• Demonstrated effective communication skills (written and oral)