Gu Mi

Gu Mi


Summary

Ph.D. in Statistics with more than eight year's experience in data analyses, statistical methodological and computational tool development. Specialize in biostatistics, statistical genetics, clinical trials, biomarkers, and drug development (oncology). Currently working as a statistician in a global pharmaceutical company, leading oncology trials across phase 1-3 and providing pharmaceutical statistical supports to a variety of functional areas. Extensive research and collaborative experience with international investigators in both academia and industry.

Clinical Trials Drugs & Devices Genetics Genomics Oncology Statistics

Institution affiliations

Work details

Research Scientist

Eli Lilly and Company
July 2014
Global Statistical Sciences
-- Clinical Project Statistician for early-phase and late-phase oncology trials: trial designs (dose-escalation schemes including novel-novel combinations, biomarker-driven designs, adaptive designs, Go/No-Go decision-making), Life-Cycle Planning (LCP), DMC reviews, Risk Management Plans (RMP), DSUR/PBRER/IB statistical reviews, and submission-related statistical planning. -- Biomarker Project Statistician for late-phase oncology compounds: experiences in data analyses from IHC/FISH/SISH and other novel platforms. Participated as statistics functional member in various regulatory (FDA/EMA/PMDA) activities. -- Experience in late-phase regulatory response and submissions (both clinical and biomarker), and Oncology Drug Advisory Committee (ODAC) meeting preparations (biomarker). -- Knowledge of current landscapes in clinical oncology and immuno-oncology, especially in NSCLC, gastric or GEJ adenocarcinoma, mCRC, HCC, breast cancer, SCCHN, and ovarian cancer. -- Extensive collaborations with researchers from academics: co-author scientific publications in peer-reviewed clinical journals and presentations in worldwide conferences and symposia. -- Presentations at major statistical conferences, including serving as session chair, etc.

Research Assistant

Oregon State University
September 2009 - June 2014
Department of Statistics
Research Assistant under the supervision of Dr. Yanming Di and Dr. Daniel W. Schafer. Concentration: statistical methodology and computational tool development for RNA sequencing data.