About this opportunity
VOLTO Consulting lists this Senior Statistical Programmer opportunity in raleigh, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
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.
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 (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
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Worksite address
raleigh, NC, 27601, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.