We're hiring a Clinical Data Engineer to own clinical trial data ingestion and harmonization pipelines on AWS for a regulated biotech data platform engagement. This is a hands-on engineering role grounded in real CDISC/SDTM/ADaM practice - not a data management or programming-only position.
Contract-to-hire | Remote (Canada)
What you'll own:
Ingestion pipelines for CRO-delivered clinical trial data
The SDTM/ADaM harmonization layer for our first study
Our end of the data exchange with statistical computing platforms
Must-haves:
Practical, hands-on CDISC experience - SDTM and ADaM structure and implementation, not just familiarity
Understanding of how data flows from EDC through to submission-ready datasets
Working knowledge of how CROs package and deliver clinical trial data
Solid AWS skills (S3, IAM, Glue or equivalent ETL)
- enough to build and operate pipelines, deep infrastructure/architecture experience not required
SQL and Python
Experience with data validation/conformance tools (e.g., Pinnacle 21)
Nice-to-haves:
Experience with major EDC systems (Medidata Rave, Veeva Vault, Oracle InForm)
Familiarity with regulatory submission packages (eCTD, FDA/EMA data standards)
Exposure to a validated/GxP computing workplace
Experience working directly with CROs on data transfer specs
Familiarity with AI-assisted development workflows
5+ years combining clinical data standards work with hands-on engineering. Apply to learn more about the engagement.