Dr. Kazem Kazempour

Dr. Kazem Kazempour’s story starts with numbers. In 1975, he became a programmer and data analyst at a genetics research institute. He was writing statistical code before most labs had computers. He published his first genetics article in 1979. From the start, he asked one question: how can data answer the questions that matter most?

The turning point came in 1991, when he joined the U.S. Food and Drug Administration as a statistical reviewer. His job was to judge whether new medicines were safe and effective enough for patients. He earned multiple FDA awards for creative problem solving and helped analyze early HIV/AIDS trials at the height of the epidemic. That work left a lasting mark: behind every statistic is a person waiting for treatment.

After the FDA, he led global biometrics at Otsuka America Pharmaceutical. Then, in 1998, he co-founded Amarex Clinical Research, a contract research organization serving pharma, biotech, and medical device teams worldwide. Over three decades, he has worked on more than 100 clinical trials. He has also contributed to hundreds of regulatory meetings covering more than 100 products. His research has appeared in journals like The Lancet. Today, he teaches statistics at George Washington University and serves on its Regulatory Affairs Advisory Board.

So why write a blog now? Because after 45 years, Dr. Kazempour believes this knowledge should not stay locked inside conference halls. He wants students, founders, and curious minds to see how medicine really gets made. This blog is his way of opening that world to you.