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USA_Data Scientist

Varite, Inc

Raleigh, NC

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JOB DETAILS
SALARY
$57.14–$58.82 Per Hour
SKILLS
Agile Programming Methodologies, Amazon Elastic Compute Cloud (EC2), Amazon Web Services (AWS), Automation, Basel III (Third Basel Accord), Biology, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Practices/Protocols, Cloud Computing, Code of Federal Regulations, Comprehensive Capital Analysis and Review (CCAR), Computer Science, Continuous Deployment/Delivery, Continuous Integration, Cost Control, Cross-Functional, Data Management, Data Science, Data Sets, DataArchitect Data Modeling Tool, DevOps, FDA (Food and Drug Administration), FDA Requirements, Financial Regulations, Git, GxP, HIPAA (Health Insurance Portability and Accountability Act), ICH Regulations, JSON, Jenkins, Lead Generation, Leadership, Licensing, Maintain Compliance, Microsoft Windows Azure, Pinnacle, Power BI, Python Programming/Scripting Language, R Programming Language, Regulations, Regulatory Compliance, Regulatory Submissions, SQL (Structured Query Language), Sarbanes-Oxley Act (SOX), Scalable System Development, Sprint Planning, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Supplier Relationship Management (SRM), System Migration, Team Lead/Manager, Validation Documentation, Vendor/Supplier Relations, XML (EXtensible Markup Language)
LOCATION
Raleigh, NC
POSTED
2 days ago
Pay Rate Range: $57.14 - 58.82/hr.
GBAM Req ID: 10782063

Job Description:
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:
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 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


 
Skills:
CategoryNameRequiredImportanceExperience
SkillCategoryTest1_MNDigital : Azure DatabricksYes1>7 years 

About the Company

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Varite, Inc

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