Clinical Data Architect

Raleigh, North Carolina
Full Time

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Job ID : 90062-1
Job Title : Clinical Data Architect
Location : Raleigh, NC
Duration : 6 months + possible extension
Rate Range: $50 - $55/hour on W2/ C2C (All inclusive) Introduction

We are seeking a highly experienced professional with extensive 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.

Required Skills & 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)
Proficiency in CDISC standards (SDTM, ADaM, define.xml)
Experience with regulatory submissions (FDA, global agencies)
Hands-on experience with Python (Pandas) and/or R (admiral, Shiny)
Experience with cloud platforms (AWS/Azure)
Strong understanding of GxP and clinical compliance frameworks
Prior work experience at client or in client's Industry

Applicants must be able to work directly for Artech on W2

Preferred Skills & 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

Day-to-Day 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
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
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)
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