Yihua Zhao

Lead a team of quantitative scientists to seamlessly integrate cancer clinical research into everyday clinical care, and to empower cancer clinical research with real world data and real world evidence.

Team Leader (April 2017 to present) of a team of 5+ statisticians working in multiple therapeutic areas (cardiovascular, metabolism, respiratory, ophthalmology, oncology, inflammation, immunology): managed resource and budget for the team, mentored and developed team members, hiring manager of summer interns and permanent statisticians. Lead Project Statistician (2015 to present) of a clinical development program in cognitive impairment associated with schizophrenia (CIAS): successfully led the POC phase II trial to EoPII stage and played an instrumental role in the development of the pivotal phase III program, the design of the phase III trials and interactions with global health authorities during EoPII interaction and phase III planning and initiating. Lead Project Statistician for several early-phase oncology clinical development programs, e.g. BETi, SMAC-MIMETIC. Lead Project Statistician (2012 to 2016) of the world wide submission and registration of Spiolto/Stiolto Respimat in COPD - one NDA and two sNDAs (SGRQ and COPD exacerbation): provided the strategic and statistical leadership in the development of CDP, pivotal phase III protocols, SAPs, submission packages and interaction with global health authorities (EoPII, Type B, pre-NDA meetings with FDA and interactions with EMA, PMDA, NMPA and other countries).

Lead Project Statistician for Spiolto/Stiolto in COPD and BETi in solid tumor clinical development program.

Leading Project Statistician for world wide NSCLC submission of nintedanib (VEGFR TKi) and lead Trial Statistician of LUME-Lung 1 (NCT00805194) and LUME-Lung 2 (NCT00806819). Lead Project Statistician for several early-phase oncology projects.

Leading Project Statistician for several oncology clinical development programs in non-small cell lung cancer (EFGR TKi afatinib, VEFGR TKi nintedanib, and combination) and hematological tumors: developed CDP and TPP, phase I to III clinical trial protocols, statistical analysis plans, and SCS and SCE. Interacted with global regulatory agencies during clinical development. Leading Trial Statistician for pivotal phase III trial of combivent respimat in COPD and supported world-wide submission and registration of combivent respimat: developed protocol and SAP, conducted and interpreted data analyses, authored CSR and publications.

Conducted in-depth statistical review of submissions of PMA, 510(k), IDE, pre-IDE for various orthopedic, neurological and contraceptive medical devices. Presented FDA statistical review and data analysis results at FDA Advisory Committee meetings. Provided statistical consultation to CDRH physicians, clinicians and engineers on topics of propensity score, meta-analysis and Bayesian statistics in study design and data analyses. Contributed to CDRH guidance development for electroconvulsive therapy devices and Bayesian statistics in medical device clinical trials.