Statistical Programmer / Clinical Data Architect

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Role: Senior Statistical Programmer / Clinical Data Architect

Location: Raleigh, NC - Local Only

(100% onsite Role Only)

Job Description:

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:
• 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
  
  

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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