James Nezamis is a biostatistician with over 30 years’ experience in the pharmaceutical and CRO industries. He has broad experience in numerous therapeutic areas, including infectious diseases, diabetes, cardiovascular disease, pain management, depression and imaging contrast agents. In the last few years James work has focused on orphan diseases. He has extensive knowledge of Phase I through Phase IV clinical trial design, analysis, data management, data monitoring committees, and regulatory submissions. He brings an in-depth knowledge of statistics, strategy and regulatory requirements, along with extensive experience in regulatory interactions.
Prior to joining Ellodi, James successfully led the biostatistics and data management teams at Insmed Inc. to bring the first approved drug to patients with NTM lung disease and at Mannkind to bring Afrezza® to market. James obtained a Master of Science degree in Statistics from Western Michigan University and holds a Bachelor of Science degree in both Applied Mathematics and Statistics. His educational background also includes extensive engineering and computer science studies.