Statistical Programmer / Clinical Data Architect

Key Responsibilities

• 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
• Develop and optimize end-to-end clinical data pipelines using SAS, Python, and R
• Build reusable SAS macro libraries and automation frameworks
• Drive migration from legacy systems to modern data architectures
• Manage cloud infrastructure components (EKS, EC2, EFS, FSx, Databricks, etc.)
• 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

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), Python (Pandas), and R (admiral, Shiny)
• Hands-on experience with cloud platforms (AWS/Azure)
• Strong understanding of GxP and clinical compliance frameworks

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)
• AWS or cloud certifications