Summary

Biostatistician with a demonstrated history of working in biotech data analysis and modeling. Skilled in sampling, forecasting models, cross-functional planning, growing teams with global portfolios, quantitative analysis, teamwork and storytelling.

With 6 years of experience in the Clinical Research Organization (CRO) industry, including over 8 years of clinical trial experience, I have a comprehensive understanding of the entire clinical trial operation process. My work encompasses various aspects of medical affairs in clinical trial research and development, including clinical development planning, protocol design, and medical support in specific areas (such as oncology, with a particular focus on immunotherapy, metabolic diseases, and rare diseases), medical monitoring, and risk control.

Previous participation in clinical trial projects includes chemical drugs, biologics (including oncolytic viruses, PD-1 antibodies, other monoclonal antibodies, antibody-drug conjugates (ADCs), vaccines, etc.), as well as medical devices. I extensively research and explore monotherapy and combination therapy approaches with different mechanisms of action, providing comprehensive strategies for investigational drug IND and NDA applications.

As the head of the medical team, I have a strong awareness of promoting close collaboration among cross-functional teams and effectively coordinating communication between project departments. Grounded in evidence-based research and rooted in medical insights, I focus on key project milestones, engage in extensive communication from multiple angles, and actively drive project progress while ensuring project quality.

Work Experiences

Chief Data Officer at NJS Associates China branch office / Biostatistician at NJS Associates 2019.2 – current China /2022.8 – current NJ

Platform trial design for cancer clinical trials (e.g. a prostate cancer master protocol database aiming for platform trial design for prostate cancer patients, achieving identical statistical power with 30%-50% fewer patients than a traditional design)

Adaptive clinical trial design including Bayesian design for top tier clients (Merck, Moderna...) in US

Handled multiple studies including oncology, mRNA, ADT from PhI to PhIII. Designed SAP; Implemented statistical analyses described in the protocol; Answered FDA statistical related questions

Developed an automated program for meta-analysis of KM survival curve, saved biostatistician 80% time

Data Scientist at Flagship Pioneering (Moderna founding VC) 2018.2 – 2019.1 Cambridge, MA

Quantitative researcher on clinical trial data

Data mining from multi-sources (Public news and paid database Bloomberg terminal, BioCentury, Thomson Reuters)

Applied machine learning algorithms (Cubist, BRT, RFT) on text mining from NASDAQ Biotech listed company’s press releases and model building

Postdoctoral Associate at Yale School of the Environment 2017.2 – 2018.1 New Haven, CT

Sampling design and power analysis for clinical trials check of Biogen

Collaborated with FDA on clinical trial sampling size validation

Quantitative researcher on machine learning models from development through testing and validation (https://github.com/DrylandEcology/STEPWAT2

Developed Monte-Carlo complete random simulation method on time series forecasting; applied machine learning (BRT, RFT) on investigating key attributes (accepted by USDA)

Storyteller and data visualization expert; Tutored PhD and Master students of Gregoire Lab, and Lauenroth Lab at Yale on AI

Education

Chinese Academy of Sciences 2012.9 – 2017.7 Ph. D., Environmental Engineering (Topic:Biostatistics)

Yale School of the Environment 2016.2 – 2017.1 Visiting Scholar, Biostatistics with Biostatistician AAAS Fellow Prof. Timothy Gregoire

National Taiwan University 2015.9 – 2015.12 Visiting Scholar, Biostatistics

Beijing Forestry University – Liangxi Honored Class 2008.9-2012.7 B.S. Biostatistics

Skills & Expertise

R, SAS, Python, Sampling, NLP, SQL, Tableau, PowerPoint; Multi-tasks management; Teamwork; Storytelling

Peer-reviewed papers

13 publications & 7 international invited talks

https://scholar.google.com/citations?user=vahT6xIAAAAJ&hl=en

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