James Gunter

Vice President, Biostatistics and Statistical Programming, at Fortrea

Role: Vice President, Biostatistics and Statistical Programming at Fortrea
Location: Raleigh, NC, US
LinkedIn followers: 500 followers

About James Gunter

Senior leadership of global clinical research teams. Focused on providing high quality services to support regulated environments of Statistical Programming.Specialties: Operations Management and Innovation, Project Management, Process Engineering, Vendor and Client Management, FDA 21 CFR Part 11 and GCP Compliance, Software Development Lifecycle (SDLC)

Experience

Vice President, Biostatistics and Statistical Programming
Fortrea
Jun 2025 — Present · NC, US
Global head of Biostatistics and Statistical Programming including responsibilities for Full-Service and Functional Service Provider lines of business.* Responsible for global team working in over 30 countries that serve pharmaceutical clients of all sizes with focus on end to end aspects of statistics and analysis* Thought leader and long-time technical geek

Education

The University of North Carolina at Chapel Hill
Bachelor of Science, Biology
1991 — 1995

Skills

Data Analysis
Clinical Trials
Ich-Gcp
Sas Programming
Protocol
Pharmaceutical Industry
Clinical Development
Databases
Project Management
Business Process Management
Clinical Data Management
Oracle Clinical
Data Management
Etl
Enterprise Software
Crm
Saas
Business Intelligence
Biostatistics
Operations Management
Database Administration
Sdlc
Edc
Ctms
21 Cfr Part 11
Regulatory Submissions
Leadership
IT Management
Cross-Functional Team Leadership
Gcp
CRO

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