Clinical Data Engineer
Summary
Contract-to-hire engineer owning clinical trial data ingestion and SDTM/ADaM harmonization pipelines on AWS for a regulated biotech data platform engagement, including data exchange with statistical computing platforms. Core stack: AWS (S3, IAM, Glue), SQL, Python, and hands-on CDISC standards.
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 environment
- 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.