Dr. James Koziol is a biostatistician and data analyst with over 30 years of experience in clinical affairs. He has a demonstrated record of achievement in research, in project leadership, and as a manager, with particular expertise in statistical strategy and FDA interaction. Jim has extensive experience in FDA negotiations with pre-IDE, design review, drug and PMA submissions. Dr. Koziol was the chief biostatistician for the application leading to FDA approval of cladribine for hairy cell leukemia.
For the past 25 years, first at the UCSD Cancer Center and then at the Scripps General Clinical Research Center, Dr. Koziol has been extensively involved in the design and analysis of preclinical and clinical studies in a variety of areas, including, cardiology, immunology, neurology, and oncology. This has entailed: collaboration with co-investigators concerning study designs; the preparation of analysis plans and detailed specifications for analysis files, consistency checks, tables, and figures; study data management and subsequent statistical analyses; interpretation of findings and preparation of study reports. Jim’s proficiency in technical writing extends to protocols, statistical analysis plans, and grant and FDA submissions.
Dr. Koziol earned his Doctorate and Master of Science in Statistics, and a Bachelor of Science in Mathematics from the University of Chicago. His publication record includes over 300 papers, including collaborations with researchers at Scripps, UCSD, Sanford Burnham Prebys, and commercial and consulting companies; clinical trials publications; and research reports in bioinformatics, biomathematics, and statistics.