Background
Mr. Van Orden's background includes protocol design, regulatory strategy, propensity scores, scale validation, team leadership and development, optimal study design, and sample size calculation.
Education
Mr. Van Orden received his Bachelor's degree in Statistics, with a minor in Psychology, from Brigham Young University. He also received a MS and PhD ABD in Statistics from NC State University.
Experience
Prior to joining MCRA, Mr. Van Orden worked at the Food and Drug Administration as a Mathematical Statistician, where he reviewed hundreds of submissions to the FDA in every stage of the review process, from the planning stages of the clinical trial design to the analysis of the clinical data, and finally to the design of the post market studies. He provided expertise in a wide array of statistical tools and methods, including categorical data analysis, clinical trial and epidemiological methodology, generalized linear models, randomization methods, longitudinal analysis, non-parametric models, adaptive designs, survival analysis, and bias assessment. Mr. Van Orden also worked on developing new statistical methods to address the unique problems that arose in various clinical trials.
Overview
Mr. Van Orden is a Mathematical Statistician with a clear understanding of the regulatory statistical requirements for study designs and statistical analysis plans. He has extensive experience in medical device clinical research in a wide range of device-areas, having presented before FDA/CDRH advisory panels for orthopedic, respiratory, neurologic, and aesthetic devices.