Kelley Wekheye
Director, Biostatistics @Otsuka Pharmaceutical Companies (U.S.)
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WORK HISTORY
Director, Biostatistics @Otsuka Pharmaceutical Companies (U.S.)
EDUCATION
The University of North Carolina at Chapel Hill
DrPH, Biostatistics
Northern Illinois University
M.S., Applied Probability and Statistics
University of Evansville
B.S., Actuarial Science
SKILLS
ABOUT KELLEY WEKHEYE
Over Twenty years of experience providing statistical support for Phase clinical trials as a Lead Biostatistician and/or Biostatistical Oversight. Lead and execute the statistical aspects for clinical development programs, including analysis plans, statistical analysis, study design, clinical study report authoring, DSURs, IBs, and abstracts/publications. Cross-functional collaboration on studies in numerous therapeutic areas, including Neuroscience, Mental Health, Oncology, Metabolic, Pain, and Vaccine. Experienced in several statistical procedures, including crossover design, linear and nonlinear models, longitudinal data analysis, ANOVA/ANCOVA, multivariate analyses, logistic regression, survival analysis, missing data imputation, and categorical data analysis.Specialties: Phase Depression (Major Depressive Disorder, Bipolar Depression, Postpartum), Migraine, Parkinson\'s Disease, Alzheimer\'s Disease studies. Phase Osteoarthritis Pain and Dental Pain analysis methods. NDA submissions. Early Development study design and analysis methods, including bioequivalence, bioavailability, dose-escalation, dose-proportionality, 2-5 period crossover design.
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