Clinical Data Engineer

Original job posting

Own the ingestion and harmonization pipelines for clinical trial data on AWS. Manage the data exchange between CROs and statistical computing platforms to ensure submission-ready datasets.

Job details

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.

What you’ll do

Own the ingestion and harmonization pipelines for clinical trial data on AWS. Manage the data exchange between CROs and statistical computing platforms to ensure submission-ready datasets.

Requirements

Requires 5+ years of experience combining clinical data standards (CDISC/SDTM/ADaM) with hands-on engineering in Python, SQL, and AWS. Must have practical experience with data validation tools like Pinnacle 21 and understanding of EDC data flows.

Listed skills

• SQL · Preferred
• Amazon Web Services · Preferred
• Python · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• CDISC
• SDTM
• ADaM
• AWS
• S3
• IAM
• AWS Glue
• SQL
• Python
• Pinnacle 21
• EDC Systems
• GxP
• eCTD
• Data Ingestion
• Data Harmonization
• Clinical Trial Data

Job areas

• Data & Analytics
• Healthcare
• Engineering
• Technology
• Science & Research