About BiostatHaven and Ed Lakatos

Ed Lakatos PhD, founder of Biostathaven, has a unique and effective approach to solving biostatistical problems (See Ed's CV).

Shortly after receiving his doctorate in 1978, Ed joined the Biostatistics Research Branch (BRB), which was part of the National Heart Lung and Blood Institute, at the NIH. The BRB, led at the time by Dave DeMets, had a long history of excellence in biostatistics and clinical trial research. When Dave left to become chair of the department he currently heads at the University of Wisconsin, he was succeeded by Janet Wittes.

At the NIH, Ed was involved in the design, implementation, and day-to-day activities of many large clinical trials. In response to the design complexities of the SHEP trial, initiated in 1984, Ed developed the now well-known Markov model approach for calculating sample size and power for clinical trials (Controlled Clinical Trials, 1986). He soon adapted it for the log rank statistic (Biometrics, 1988). At the time Ed joined the NIH, interim and group sequential analyses were becoming an important issue in clinical trials, especially at the NIH. In 1983, Lan and DeMets published their seminal article that introduced the spending function. Ed initially extended the Markov procedure to group sequential trials while participating in the design the Women's Health Initiative, one of the largest and most important clinical trials of the NIH. Ed was also involved in research on weighted log rank statistics (Zucker and Lakatos, Biometrika 1992).

In 1992, Ed joined the Pharmaceutical Industry, initially at G. H. Besselaar Associates (now COVANCE), a clinical research organization (CRO). The choice join a CRO was largely influenced by Ed's desire to get broad exposure to the pharmaceutical industry, as well as benefit from the wisdom of his new supervisor, Dr. Mary Johnson, who had been a leader at the FDA.

In the Pharmaceutical Industry, Ed rose rapidly to positions of increasing importance and responsibility (Director of Statistics at Searle, and Senior Director of Biostatistics and Data Management at Forest), leading a group as large as 70 people. Ed took a central role in the design, development and approval process of many drugs in many therapeutic areas (Celecoxib, one of the first Cox-II inhibitors, Celexa, an SSRI, etc., and many others ) Ed continued to play a pivotal role in the design and analysis of large trials in numerous therapeutic areas (CHF (RALES), CHD (TIMI 9), CVD (OPUS, EXCITE, CONVINCE). He also served as dissertation advisor for a graduate student who received her Ph.D. in 1999.

Ed began his consulting business, BiostatHaven Inc, in 2002. This position allowed Ed to focus on his statistical and clinical trial savvy, and pursue his research interests. In 2005, BiostatHaven Inc.c with Ed as Principle Investigator, was awarded a grant from the NIH to develop statistical software that would make widely available the methods he had developed for the design of clinical trials, especially with interim analyses. STOPP® software is a result of that endeavor. In 2007, Ed was elected a fellow of the American statistical Association.

Click here for Edward Lakatos's CV.