Senior Manager, Technical SME Standards
Core
Serve as the liaison for the Data Standards organization with Clinical Data Engineering, CDS Systems & IT, and external stakeholders to implement and enhance clinical data standards and automation tools.
Role type
Senior Manager, Technical SME (Data Standards)
Builds
Tools for end-to-end data lineage, automation workflows for statistical analysis (tables, figures, listings), and integration of Rawplus standards between data collection and SDTM.
Domain
Biopharmaceuticals / Clinical Data Management / Regulatory Compliance (CDISC, FDA, ICH)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Drug development lifecycle knowledge, Clinical research metadata management, CDISC standards (SDTM, ADaM), FDA/ICH/GCP regulations, Python or R programming, GitHub collaboration, End-to-end data pipeline development
Preferred skills
Vendor management, Cross-functional stakeholder relationship building, AI-assisted development tooling
Technologies
Python, R, GitHub, Rawplus, SDTM, ADaM
Responsibilities
Establish tools for data lineage and impact assessments; Collaborate on testing and implementing technology solutions for standards automation; Oversee system operations for in-house and vendor platforms; Develop workflows to integrate Rawplus standards; Automate components of statistical analysis; Champion Digital Data Flow principles to reduce manual effort
Seniority
Senior Manager, hands-on IC with team leadership
