Data Standards & Metadata Governance Lead

Overview

Senior Manager, Biomedical Data Stewardship role supporting Amgen's Data Element Standards and Precision Medicine and Clinical Data Hub needs through India-based execution, working with global BMDS and cross-functional teams.

What you'll do

• Collaborate with Clinical Data Hub 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 clinical trial development 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.

What you'll need

• 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.
• Willingness to learn the MDR and underlying data tables (MDR experience is not necessary).
• 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, statistics/biostatistics, programming, life science, business administration, or related discipline, or equivalent combination of education and experience, with 12-17 years of professional experience.

Nice to have

• 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).

Details

• Location: Hyderabad, India.