Statistical Programmer / Clinical Data Architect

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:

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

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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