Clinical Data Architect for Raleigh, NC (Local Candidates Only)

Hi,

My name is Rohit Chauhan, and I am a Staffing Specialist at Novia Infotech LLC. I am reaching out to you on an exciting job opportunity with one of our clients.

 

Job Title: Clinical Data Architect

Location: Raleigh, NC (Local Candidates Only)

Position Overview

We are seeking a highly experienced Senior Statistical Programmer / Clinical Data Architect with 15+ years of expertise in clinical data programming, regulatory submissions, CDISC standards, and cloud-based analytics platforms. The ideal candidate will lead clinical data modernization initiatives, regulatory submission processes, and enterprise-scale data platform transformations within GxP-regulated environments.

This role requires deep expertise in SDTM, ADaM, define.xml, SAS programming, Python, R, AWS/Azure cloud technologies, and SAS Viya architecture, along with strong leadership capabilities to drive global clinical data and analytics initiatives.

Key Responsibilities

Clinical Data Programming & Regulatory Submissions

• Design, develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards.
• Lead creation and validation of define.xml, aCRF/eCRF annotations, reviewer guides, and submission-ready deliverables.
• Develop and optimize automated clinical data submission pipelines for FDA and global regulatory agencies.
• Ensure compliance with GxP, HIPAA, 21 CFR Part 11, ICH E6, and other regulatory requirements.
• Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and Medical Writing teams throughout the submission lifecycle.
• Perform quality reviews and validation of clinical datasets, tables, listings, and figures (TLFs).

Data Engineering & Automation

• Architect and implement end-to-end clinical data pipelines using SAS, Python, R, and SQL.
• Develop reusable SAS macro libraries, automation frameworks, and metadata-driven programming solutions.
• Build scalable and efficient clinical data processing workflows utilizing modern data formats and cloud-native architectures.
• Lead migration of legacy clinical data platforms to modern analytics ecosystems.
• Implement data quality, lineage, traceability, and reproducibility standards across clinical datasets.

Cloud & Platform Engineering

• Lead deployment, administration, and optimization of SAS Viya environments on AWS and Azure platforms.
• Manage cloud infrastructure components including EKS, EC2, EFS, FSx, Databricks, and related services.
• Design secure, scalable, and compliant cloud-based clinical data architectures.
• Implement FinOps practices to optimize cloud resource utilization and operational costs.
• Evaluate and onboard next-generation analytics and data engineering platforms including Databricks and DBT.

Leadership & Stakeholder Management

• Lead cross-functional teams across onsite, offshore, and global delivery locations.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Data Management, Quality Assurance, and IT stakeholders.
• Drive Agile delivery methodologies, sprint planning, resource allocation, and project governance.
• Mentor junior programmers, data engineers, and statistical programmers.
• Manage vendor relationships, technology evaluations, licensing strategies, and platform roadmaps.

Compliance & Governance

• Ensure compliance with FDA regulations, GxP requirements, HIPAA, 21 CFR Part 11, and global regulatory standards.
• Maintain audit-ready documentation, validation records, SOPs, and system qualification artifacts.
• Establish governance frameworks supporting data integrity, traceability, reproducibility, and regulatory readiness.
• Support internal audits, inspections, and regulatory submissions.

Required Qualifications

• Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, Biostatistics, Data Science, or a related field.
• 15+ years of experience in Clinical Data Management, Statistical Programming, and Regulatory Submissions.
• Extensive experience with:
• SAS Base, SAS Macro, SAS SQL, ODS, SAS STAT, and SAS Graph
• CDISC Standards (SDTM, ADaM, Define.xml)
• FDA and global regulatory submission processes
• Clinical trial data management and validation
• Hands-on expertise with:
• Python (Pandas, NumPy)
• R Programming (Admiral, Shiny)
• SQL and database technologies
• AWS and/or Azure cloud platforms
• Strong knowledge of GxP, HIPAA, 21 CFR Part 11, ICH E6, and clinical compliance frameworks.
• Experience implementing automated clinical data workflows and submission processes.

Preferred Qualifications

• Experience with SAS Viya architecture, administration, and platform engineering.
• Hands-on experience with Databricks, DBT, Snowflake, or modern data engineering platforms.
• Knowledge of CI/CD pipelines using Jenkins, Git, GitHub, GitLab, or Azure DevOps.
• Experience implementing cloud-native analytics and machine learning solutions.
• Exposure to financial regulatory frameworks such as Basel III, CCAR, SOX, or OCC is a plus.
• AWS, Azure, or cloud platform certifications preferred.

 

 

Rohit Chauhan IT Recruiter E: rohit.c@noviainfotech.com www.noviainfotech.com A: 4421 Avenida Ln, McKinney, TX, 75070

 

 

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