Hana Mekonnen has over 15 years of experience in clinical research and pharmaceutical product development as a biostatistician. She has prepared, submitted and defended multiple Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports to the U.S. FDA for product approvals. Ms. Mekonnen is responsible for developing statistical analysis plans (SAPs), creating programs in SAS to analyze data and providing statistical opinions of analyzed data. She also works with sponsors to develop protocols, study reports and data analyses to be presented to the FDA. Previously, she worked as a statistician for a large pharmaceutical company, and she has taught statistics courses at the university level. Ms. Mekonnen received a master's degree in statistics from Columbia University.
Her areas of expertise include:
- Adaptive trial design
- FDA advisory committee and DSMC presentations
- Statistical simulations
- Interim and exploratory analysis