Python R Developer Jobs in Durham, NC (NOW HIRING)

Job Description: Local to Raleigh, NC  Only!
Role Overview
We are seeking a highly experienced Senior Statistical Programmer / Clinical Data Architect with 15+ 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.
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Key Responsibilities
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
Data Engineering & Automation
•       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
Cloud & Platform Engineering
•       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)
Leadership & Stakeholder Management
•       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
Compliance & Governance
•       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
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Required Qualifications
•       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
•       Strong expertise in:
o       SAS (Base, Macro, SQL, ODS, STAT, Graph)
o       CDISC standards (SDTM, ADaM, define.xml)
o       Regulatory submissions (FDA, global agencies)
•       Hands-on experience with:
o       Python (Pandas) and/or R (admiral, Shiny)
o       Cloud platforms (AWS/Azure)
•       Strong understanding of GxP and clinical compliance frameworks
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Preferred Qualifications
•       Experience with SAS Viya architecture and administration
•       Familiarity with Databricks, DBT, or modern data engineering tools
•       Knowledge of CI/CD tools (Jenkins, Git)
•       Experience in financial/regulatory environments (Basel III, CCAR, OCC) is a plus
•       AWS or cloud certifications
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Key Skills
•       Clinical Data Standards: SDTM, ADaM, CDISC
•       Programming: SAS, Python, R, SQL
•       Cloud: AWS, Azure
•       Tools: Pinnacle 21, Git, Jenkins, Power BI, Grafana
•       Methodologies: Agile, DevOps, Data Governance