Clinical Data Engineer

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.