•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.
Key Skills / Knowledge:
Data Standards & Technical Expertise
•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.
Collaboration & Communication
•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
Process & Governance
•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.
