Clinical Data Architect
Purple Drive
Overview: Key Skills Required:
- SAS (Base, Macro, SQL, ODS, STAT, Graph)
- CDISC Standards (SDTM, ADaM, Define.xml)
- FDA & Global Regulatory Submissions
- Python (Pandas) and/or R (Admiral, Shiny)
- AWS/Azure Cloud Platforms
- SAS Viya
- Clinical Data Management & GxP Compliance
- Data Engineering & Automation
- Design, develop, and validate SDTM and ADaM datasets in compliance with CDISC standards.
- Lead define.xml generation, eCRF/aCRF annotations, and submission-ready deliverables.
- Build and optimize automated regulatory submission pipelines.
- Architect end-to-end clinical data pipelines using SAS, Python, and R.
- Lead SAS Viya implementations and cloud platform modernization initiatives.
- Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines.
- Collaborate with clinical, statistical, regulatory, and IT stakeholders globally.
- Drive data governance, audit readiness, and platform transformation initiatives.
- Databricks, DBT
- Jenkins, Git, CI/CD
- AWS Certifications
- Experience in regulated environments and large-scale data modernization programs
Vacancy posted 1 day ago
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