Principal Clinical Data Standards Consultant
Core
Design and analyze clinical trials, interpret complex medical data, and develop tools for clinical data standards compliance.
Role type
Principal Clinical Data Standards Consultant
Builds
Data management processes, tools, training materials, and compliance frameworks for clinical trials.
Domain
Clinical research / Pharmaceutical data standards
Required skills
SDTM expertise, SAS programming, R programming, CDISC standards knowledge, regulatory submission knowledge, data management process design, team leadership, cross-functional collaboration
Preferred skills
Experience with CDASH, ADaM, define-XML, industry trends analysis
Technologies
SAS, R, CDISC standards (SDTM, CDASH, ADaM, define-XML)
Responsibilities
Develop tools for standards implementation and compliance; Collaborate on data collection strategies; Create training and reference materials; Manage data management processes; Monitor regulatory updates
Seniority
Principal, hands-on IC with team leadership
