Expert Profile
23+ years medical device experience in Biostatistics, Clinical Research, Regulatory Affairs, Quality Assurance and Medical Device Manufacturing. Former Manager of Biostatistics with Johnson & Johnson
***** Research Partners (Founded 2011)
Vice President Biostatistics
Clinical Research
Manager Biostatistics, Johnson & Johnson 4 Years
Biostatistician III, Project Manager Biostatistics 7 years (J & J)
Clinical Research Associate 5 years (J & J)
Regulatory Affairs/Biostatistics/Clinical Affairs 3 years (J & J)
Statistical Quality Assurance 2 years (J & J)
Statistical Quality Assurance 1 year (Sikorsky Aircraft)
Quality Control Manager (George W. Moore - machine shop) 1 year
MS (Ph.D. course work complete) Univerisity of Tennessee Industrial and Organizational Pyschology focusing on statistics and research on human subjects.
AB, Cum Laude, Vassar College, Psychology
Regulatory Affairs Professional Society (RAC, Regulatory Affairs Certified)
Former CQE (Certified Quality Engineer)
Co-author of five articles published in Journal of Bone and Joint Surgery, a journal with a 10% acceptance rate. Many other peer reviewed journal articles and presentations. Numerous U.S. and foreign medical device patents, most as sole inventor.