William D. Mikrut
President, Principal Biostatistician – Vantage Data Designs
William D. Mikrut, M.Sc. is the President and founder of Vantage Data Designs, Inc., formerly Vertex Data Designs, Inc. Mr. Mikrut has over 18 years of industry experience and has consulted and provided data services for start-up and clinical stage biotechnology companies as well as major pharmaceutical companies. He has provided statistical input at all stages of clinical development, designed and implemented statistical strategies from early development through NDA/BLA (i.e., protocol design, sample size calculations, randomization methodologies, data monitoring boards, statistical analysis plans, clinical data management services, statistical analysis, statistical interpretation of data, NDA/BLA submissions). Mr. Mikrut has held lead responsibilities in critical communications with the FDA statisticians and international regulatory agencies. He has also provided independent assessment of clinical data for financial groups seeking to invest in biotechnology.
Mr. Mikrut earned his M.Sc. in Biometry at the University of Texas Health Science Center, Houston, Texas. After an academic biostatistician position at University of Texas Medical Branch – Galveston, Texas, Mr. Mikrut moved into private industry where his work experience included Pharmaco (now PPD) ILEX Oncology (sold to Genzyme in 2004), and Vical prior to founding his consulting company in 2006. Mr. Mikrut’s statistical career working in oncology, infectious diseases, gastrointestinal, anesthetics (pain), diabetes, wound healing, neurological diseases, dermatology, diagnostic imaging has provided the varied clinical/regulatory/statistical experience critical to organizations developing a variety of products. Mr. Mikrut has designed and implemented statistical aspects of clinical research protocols in many therapeutic areas, and with his team at Vantage Data Designs, established the logistics of data management (database design, validation, entry, queries, coding, etc.), DSMBs, statistical analysis, and defense of statistical interpretations for complex global clinical trials. He has been the primary statistical lead for several successful NDA/sNDA/BLA submissions including two oncology, two dermatology, two diagnostic imaging, and one dental anesthetic reversal agent.