Shing Lee, PhD

  • Associate Professor of Biostatistics at CUMC
Profile Headshot


Dr. Lee's research interest is in the implementation of novel designs for early stage clinical trials.  She is particularly interested in the development of novel statistical methods for dose optimization of targeted and immunotherapy cancer agents, such as methods that incorporate adverse events types and grades and patient reported outcomes for early stage trials, and methods for summarizing and visualizing adverse events that better reflect the toxicity burden of patients. 

In addition, Dr. Lee has over twenty years of experience in statistical consulting.  She has assisted numerous investigators from a variety of medical disciplines in the design, conduct and analysis of clinical studies.

Academic Appointments

  • Associate Professor of Biostatistics at CUMC

Administrative Titles

  • Director, Biostatistics, Epidemiology, and Research Design (BERD) Resource, Irving Institute for Clinical and Translational
  • Member, Herbert Irving Comprehensive Cancer Center

Credentials & Experience

Education & Training

  • BA, 1996 Berea College
  • MSc, 1998 Johns Hopkins University
  • PhD, 2009 Columbia University


Selected Publications

Biard L, Lee SM, Cheng B. Seamless phase I/II design for novel anticancer agents with competing disease progression. Stat Med. 2021 Sep 20;40(21):4568-4581.

Lee SM, Wages NA, Goodman KA, Lockhart AC. Designing dose-finding phase I clinical trials: Top 10 questions that should be discussed with your statistician. JCO Precision Oncology 2021, 5: 317-324

Lee SM, Lu X, Cheng B. Incorporating Patient-Reported Outcomes in Dose-Finding Clinical Trials. Statistics in Medicine 2020, 39(3):310-325.

Lee SM, Ursino M, Cheung YK, Zohar S. Dose finding designs for cumulative toxicities using multiple constraints. Biostatistics. 2019 Jan 1; 20(1):17-29

Lee S.M., Hershman D., Miao J., Zhong X., Unger J., Cheung Y.K. Estimating global treatment toxicity burden from adverse-event data. Cancer. 2018; 124(4):858-864

Lee S.M., Backenroth D., Cheung Y.K., Hershman D., Vulih D., Anderson B., Ivy P., Minasian L. Case example of dose optimization using data from bortezomib dose-finding clinical trials. Journal of Clinical Oncology; 2016; 34: 1395-1401

Lee S.M., Cheng B., Cheung Y.K. Continual Reassessment Method with Multiple Toxicity Constraints. Biostatistics, 2011; 12: 386-398.

Lee S.M., Cheung Y.K. Model calibration in the continual reassessment method. Clinical Trials, 2009; 6:227-238.

Global Health Activities

The DEFINE Study, United Kingdom: This project aims to develop extensions to the Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidance for early phase dose-finding trials.