Statistical Programmer / Clinical Data Architect

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. 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 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 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 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 #J-18808-Ljbffr VOLTO Consulting