Consulting

I have 20 years of drug development experience in Oncology Biostatistics, including many successful FDA interactions and drug approvals, and seven years serving as the GH of Oncology Biostatistics for the global Genentech/Roche portfolio.

I have deep experience in the design, execution, and interpretation of pivotal clinical trials for solid tumor and hematology-oncology indications, and am motivated to find the most efficient development path for each investigational agent.

My consulting services include providing strategic input on clinical development plans and study designs, serving as Statistician on independent Data Monitoring Committees (iDMCs), and advising companies ahead of key FDA interactions.

“James is a terrific leader who understands oncology drug development and in a very pragmatic way can offer innovative approaches to clinical trial designs and analysis.  James has a brilliant mind and always places the interest of patients at the center of all decisions.” - Chief Medical Officer, Biotech