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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:
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
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
Role Descriptions: Key ResponsibilitiesClinical Data Programming & Regulatory SubmissionsDesign| develop| and validate SDTM and ADaM datasets in compliance with CDISC standardsLead generation of define.xml| aCRF/eCRF annotations| and submission-ready deliverablesDevelop and optimize automated submission pipelines for FDA and global regulatory authoritiesEnsure compliance with GxP| 21 CFR Part 11| HIPAA| and ICH E6 guidelinesData Engineering & AutomationArchitect and implement end-to-end clinical data pipelines using SAS| Python| and RDevelop reusable SAS macro libraries and automation frameworksBuild scalable data pipelines including modern formats (JSON/XPT alternatives)Drive migration from legacy systems to modern data architecturesCloud & Platform EngineeringLead implementation and optimization of SAS Viya platforms on AWS/AzureManage cloud infrastructure components (EKS| EC2| EFS| FSx| Databricks| etc.)Implement FinOps practices for cost governance and optimizationEvaluate and onboard next-gen analytics platforms (e.g.| Databricks)Leadership & Stakeholder ManagementLead cross-functional teams across US| UK| and offshore locationsCollaborate with clinical| statistical| regulatory| and IT stakeholdersDrive Agile delivery and sprint planning for data and platform initiativesManage vendor relationships| tool selection| and licensing strategiesCompliance & GovernanceEnsure adherence to regulatory and audit requirements (FDA| OCC| SOX| Basel III as applicable)Maintain audit-ready documentation and validation processesImplement data governance| traceability| and reproducibility standardsRequired QualificationsBachelors or Masters degree in Computer Science| Statistics| Life Sciences| or related field15+ years of experience in statistical programming and clinical data managementStrong expertise in: oSAS (Base| Macro| SQL| ODS| STAT| Graph)oCDISC standards (SDTM| ADaM| define.xml)oRegulatory submissions (FDA| global agencies)Hands-on experience with: oPython (Pandas) and/or R (admiral| Shiny)oCloud platforms (AWS/Azure)Strong understanding of GxP and clinical compliance frameworksPreferred QualificationsExperience with SAS Viya architecture and administrationFamiliarity with Databricks| DBT| or modern data engineering toolsKnowledge of CI/CD tools (Jenkins| Git)Experience in financial/regulatory environments (Basel III| CCAR| OCC) is a plusAWS or cloud certificationsKey SkillsClinical Data Standards: SDTM| ADaM| CDISCProgramming: SAS| Python| R| SQLCloud: AWS| AzureTools: Pinnacle 21| Git| Jenkins| Power BI| GrafanaMethodologies: Agile| DevOps| Data Governance
Essential Skills: Key ResponsibilitiesClinical Data Programming & Regulatory SubmissionsDesign| develop| and validate SDTM and ADaM datasets in compliance with CDISC standardsLead generation of define.xml| aCRF/eCRF annotations| and submission-ready deliverablesDevelop and optimize automated submission pipelines for FDA and global regulatory authoritiesEnsure compliance with GxP| 21 CFR Part 11| HIPAA| and ICH E6 guidelinesData Engineering & AutomationArchitect and implement end-to-end clinical data pipelines using SAS| Python| and RDevelop reusable SAS macro libraries and automation frameworksBuild scalable data pipelines including modern formats (JSON/XPT alternatives)Drive migration from legacy systems to modern data architecturesCloud & Platform EngineeringLead implementation and optimization of SAS Viya platforms on AWS/AzureManage cloud infrastructure components (EKS| EC2| EFS| FSx| Databricks| etc.)Implement FinOps practices for cost governance and optimizationEvaluate and onboard next-gen analytics platforms (e.g.| Databricks)Leadership & Stakeholder ManagementLead cross-functional teams across US| UK| and offshore locationsCollaborate with clinical| statistical| regulatory| and IT stakeholdersDrive Agile delivery and sprint planning for data and pla, Project Code :