Eli Lilly and Company
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.