Summary: Over 25 years of achievement and increasing responsibility in clinical study design, statistical analysis methods, report writing and regulatory submissions for industry-sponsored clinical trials. Studies have included phase I through IV clinical trials, and integrated summaries of safety and efficacy. Background includes senior review and management experience within the Biostatistics function.Biostatistics/programming experience: Experimental design; linear models; survival analysis including multiple event models; longitudinal data analysis including mixed effects and GEE models for repeated measures; categorical data analysis; group sequential methods; multiplicity control using closed testing methods, including gatekeeping procedures; sensitivity analyses to assess missing data assumptions, including pattern-mixture and other missing not at random models; analysis of crossover designs, thorough QT/QTc trials; statistical methods for testing dose proportionality, bioequivalence and non-inferiority. Familiar with various statistical software packages including SAS, EaST and nQuery; proficient in MS Word and Excel.Medical indications: Neurology; Psychiatry; Respiratory disease, rare disease