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Position: SAS Viya Developer
Location: Raleigh, NC
Duration: Contract
Role Overview
Clinical Data Programming & Regulatory Submissions
Position: SAS Viya Developer
Location: Raleigh, NC
Duration: Contract
Role Overview
- We are seeking a highly experienced SAS Viya devloper with experience between 5 to 10 years of expertise in clinical data programming, CDISC standards, and cloud-based analytics platforms. The ideal candidate will lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments.
- This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization initiatives.
Clinical Data Programming & Regulatory Submissions
- Design, develop, and validate SDTM and ADaM datasets in compliance with CDISC standards
- Lead generation of define.xml, aCRF/eCRF annotations, and submission-ready deliverables
- Develop and optimize automated submission pipelines for FDA and global regulatory authorities
- Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines
- Architect and implement end-to-end clinical data pipelines using SAS, Python, and R
- Develop reusable SAS macro libraries and automation frameworks
- Build scalable data pipelines including modern formats (JSON/XPT alternatives)
- Drive migration from legacy systems to modern data architectures
- Lead implementation and optimization of SAS Viya platforms on AWS/Azure
- Manage cloud infrastructure components (EKS, EC2, EFS, FSx, Databricks, etc.)
- Implement FinOps practices for cost governance and optimization
- Evaluate and onboard next-gen analytics platforms (e.g., Databricks)
- Lead cross-functional teams across US, UK, and offshore locations
- Collaborate with clinical, statistical, regulatory, and IT stakeholders
- Drive Agile delivery and sprint planning for data and platform initiatives
- Manage vendor relationships, tool selection, and licensing strategies
- Ensure adherence to regulatory and audit requirements (FDA, OCC, SOX, Basel III as applicable)
- Maintain audit-ready documentation and validation processes
- Implement data governance, traceability, and reproducibility standards
- Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, or related field
- 15 years of experience in statistical programming and clinical data management
- SAS (Base, Macro, SQL, ODS, STAT, Graph)
- CDISC standards (SDTM, ADaM, define.xml)
- Regulatory submissions (FDA, global agencies)
- Hands-on experience with:
- Python (Pandas) and/or R (admiral, Shiny)
- Cloud platforms (AWS/Azure)
- Strong understanding of GxP and clinical compliance frameworks