Dr. Michael Ghebre holds an MSc in Medical Statistics from the London School of Hygiene and Tropical Medicine (LSHTM) and a PhD in Biostatistics from the University of Leicester, UK. He has extensive experience working across academia and industry (including Allergy Therapeutics, TEVA, GSK, and AstraZeneca), and CRO companies (hVIVO, Veramed, Certara) as a statistician supporting the design of clinical trials from Phase I (e.g., bioequivalence, dose-escalation, and dose-proportionality) to Phase II, Phase III, and Phase IV (post-approval).
His expertise includes designing adult and paediatric clinical trials (power and sample size calculations, and supporting synopsis/protocol, statistical analysis plan (SAP), and clinical study reports (CSR) development), analyzing complex data, making data-driven decisions, budgeting and overseeing CROs on behalf of the Sponsors, supporting trial submissions, and dealing with regulatory bodies in the US (FDA) and EU (PEI and EMA/PDCO).
He has a strong background in statistical methodologies such as adaptive Bayesian design, Bayesian Dynamic Borrowing (BDB), and implementing estimands and sensitivity analysis, mixed models, survival analysis, missing data imputation, meta-analysis, modeling structured data, predictive modeling using classical or Bayesian approaches, and Machine Learning/AI techniques (such as clustering, classification, and data reduction).
Many of Dr Ghebre’s publications can be found here.