Manager - Data Standards, SDTM Programming (Hybrid) (all genders) (full-time, regular)
Core
Define and maintain clinical data standards (SDTM, ADaM, CDASH) and oversee SDTM programming for regulatory submissions to support pipeline activities.
Role type
Manager, Clinical Data Standards & SDTM Programming
Builds
Regulatory submission datasets (SDTM, define.xml, annotated CRF) and industry-aligned data standards
Domain
Clinical Research / Biopharmaceuticals / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SDTM programming, CDISC standards (SDTM, ADaM, CDASH), regulatory submission documentation, cross-functional team leadership, standards development, data review rules definition
Preferred skills
ADaM standards, TLF standards, CDISC team participation, process improvement
Technologies
CDISC, SDTM, ADaM, CDASH, define.xml
Responsibilities
Define data collection, review rules, and mapping standards; Provide feedback on CRF design and SDTM datasets; Oversee creation of SDTM datasets and submission documentation; Consult on conformance issues and resolve data/metadata problems; Represent company interests in industry standards projects
Seniority
Manager, hands-on IC with team oversight