Pharmaceutical industry statistician with 35 years of experience working for pharmaceutical, biotechnology, and contract research organizations: Extensive experience in the statistical design and analyses methods of randomized clinical trials; experience in all major therapeutic areas, and all phases of clinical development;Broad knowledge of statistical issues in pharmaceutical drug development, US and global regulatory affairs, and Health Technology Assessment;Excellent oral and written communication skills; ability to communicate effectively with all levels of an organization;Experience in presenting to and interacting with regulatory agencies and collaborating with statistical and medical knowledge leaders;Experience in building and leading statistics and statistical programming organizations and innovating statistical processes.Ph.D. degree in Statistics from Temple University. Research interests include group sequential methods of evaluating efficacy and futility, evidence-based trial design and application of Bayesian principles, Health Technology Assessment methods for clinical evidence, and statistical leadership.
Listed skills include Biostatistics, Management, Statistical Programming, Clinical Trials, and 13 others.