Dr. Todd Gross (Allergan Medical & PSTAT UCSB)

Title: Statistical Application, and the Role of Biostatistician, in Pharmaceutical and Medical Device Development

Abstract: Statistical theory and application offer fundamental tools for the development and evaluation of new drugs and medical devices. During each phase of development, accept/reject decisions must be made based on sampled experimental data, culminating in decisions by regulatory and reimbursement agencies to approve or reject the product. The spectrum of statistical models and methods used, and their impact on corresponding study design and objectives, sample size, measures of clinical outcome, hypothesis tests and multiplicity, will be presented. In addition, the role of biostatistician as practitioner, project manager, communicator, and advocate for the application of statistically-based decision making within the biotech industry will be discussed.