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OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018) BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Li, Yisheng eRA COMMONS USER NAME (credential, e.g., agency login): YISHENG POSITION TITLE: Associate Professor EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY FIELD OF STUDY Beijing University, Beijing, China BS 7/1991 Probability & Statistics Zhongshan University, Guangzhou, China MS 6/1994 Probability & Statistics University of Toledo, Toledo, OH MS 8/1998 Statistics University of Michigan, Ann Arbor, MI PHD 12/2003 Biostatistics A. Personal Statement I have a broad background in biostatistics, with specific training and expertise in longitudinal data analysis and study design, Bayesian adaptive clinical trial design, Bayesian nonparametrics, missing data methods, and mediation analysis. I have served as a co-investigator or primary statistician on over 30 NIH-funded grants in behavioral science, health disparities research, and clinical trials, including as director of the biostatistics and data management core of a P60 Center of Excellence Grant, and a key statistical collaborator in a Stand Up To Cancer Dream Team Translational Research Grant. I have overseen the statistical design, conduct and analysis, and assisted in the interpretation of analysis results and preparation of manuscripts, in all these collaborative projects. 1. Cofta-Woerpel L, McClure J, Li Y, Urbauer D, Cinciripini PM, Wetter DW. Early cessation success among women attempting to quit smoking: trajectories and volatility of urge and negative mood during the first post-cessation week. Journal of Abnormal Psychology 2011; 120(3):596-606. PMCID: PMC3153568. 2. Basen-Engquist K, Carmack CL, Li Y, Brown J, Jhingran A, Hughes DC, Perkins HY, Scruggs S, Harrison C, Baum G, Bodurka DC, Waters A. Social cognitive theory predictors of exercise behavior in endometrial cancer survivors. Health Psychol 32(11):1137-48, 11/2013. PMCID: PMC4057057. 3. Mayer IA, Abramson VG, Isakoff SJ, Forero-Torres A, Balko JM, Kuba MG, Sanders ME, Yap JT, Van den Abbeele AD, Li Y, Cantley LC, Winer E, Arteaga CL. A SU2C phase Ib study of pan-PI3K inhibitor buparlisib with letrozole in ER+/HER2-negative metastatic breast cancer. Journal of Clinical Oncology 2014; 32(12):1202-1209. PMCID: PMC3986383. 4. Vidrine JI, Spears CA, Heppner W, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness based addiction treatment (MBAT) for smoking cessation: A randomized clinical trial. Journal of Consulting and Clinical Psychology. 2016 May 23. [Epub ahead of print] [PubMed - in process] B. Positions and Honors Positions and Employment 1998-1999 2002 2002 2004-2010 Parke-Davis Pharmaceutical Research (Pfizer Inc.), Ann Arbor, MI, Research Assistant Wyeth Research, Collegeville, PA, Summer Intern Boron, Lepore & Associates, Cardinal Health, San Diego, CA, Consultant Assistant Professor, Department of Biostatistics, Division of Quantitative Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX 2008 Visiting Assistant Professor, Department of Statistics, Rice University, Houston, TX 2010 Visiting Assistant Professor, Department of Statistics, Rice University, Houston, TX 2010-present Associate Professor, Department of Biostatistics, Division of Quantitative Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX Other Experience and Professional Memberships 1999-2002 Research Assistant, University of Michigan, Ann Arbor, MI 2003 Research Assistant, University of Michigan, Ann Arbor, MI 2006-2007 President, Houston Area Chapter, American Statistical Association 2008 Program Committee Member, Joint Statistical Meetings, American Statistical Association 2009 Center for Scientific Review Cancer Biomarkers Study Section -- Special Emphasis Panel #10, NIH, Internet Assisted Reviewer 2010-2016 Member of Editorial Board, Journal of Biometrics and Biostatistics 2011-present Associate Editor, BMC Medical Research Methodology 2012-present Associate Editor, The American Statistician Honors 1988 1992 1994 Merit-award recipient, Beijing University, Department of Probability and Statistics Merit-award (first prize) recipient, Zhongshan University, Department of Mathematics Title winner of "Outstanding Graduate Student," Zhongshan University, Department of Mathematics 2003 Fellowship, University of Michigan, Department of Biostatistics 2007 Travel Award, Current and Future Trends in Nonparametrics conference, Columbia, SC 2008 Early Career Researcher Travel Award, 9th World Meeting of the International Society for Bayesian Analysis (ISBA), Hamilton Island, Australia, ISBA 2009-present Acceptance into Cambridge Who's Who among Executives, Professionals and Entrepreneurs, Cambridge Who's Who 2009 Best Poster Presentation, The International Workshop on Objective Bayes Methodology, Philadelphia, PA, The International Society for Bayesian Analysis 2009 Young Researcher Travel Award, The 11th Annual Winter Workshop on Semiparametric Methodology, Gainesville, FL 2010-2011 Ranked #3 for a few months in the 10 most-accessed Biometrics papers, The International Biometric Society C. Contributions to Science 1. The uniform shrinkage priors (USPs) for the random-effect variance or covariance matrix in Bayesian linear or generalized linear mixed models were developed in 1999 and 2000. This approach provided an excellent alternative to the commonly used diffuse proper priors, which are known to have issues of posterior near-impropriety and sensitivity of the inference to the prior specification. Despite the satisfactory performance of the USPs, this approach has not been widely used because it was only developed for simple two-stage hierarchical models, due to both conceptual and technical difficulties in extending the method to more general hierarchical models. I extended the definition of the USP to semiparametric mixedeffects models and showed desirable properties of the new prior both analytically and empirically via simulations. Further extension of this prior specification in a general class of mixed-effects models is currently underway. In all the work, I developed the original idea of the extension and carried out most of the modeling and implementation work that has led to the publication of the following paper. a. Li Y, Lin X, Müller P. Bayesian inference in semiparametric mixed models for longitudinal data. Biometrics 2010; 66(1), 70-78. PMID: 16984320. PMCID: PMC3081790. 2. Nonparametric modeling of an unknown distribution, in particular, using the Dirichlet process prior, is at the center of robust inferences in Bayesian hierarchical models. When this approach is used in random-effects model, an identifiability issue arises which, if not addressed, will result in incorrect and seriously misleading inferences for the fixed effects that are often of scientific interest. I formally pointed out the issue and proposed a simple yet effective adjustment to inference based on analytic evaluation of the posterior moments of the fixed effects that addressed the identifiability issue. This work has solved a long-standing identifiability problem in nonparametric Bayesian inference using the Dirichlet process prior, thus allowing its wide use for valid inferences in Bayesian hierarchical models. a. Li Y, Müller P, Lin X. Center-adjusted inference for a nonparametric Bayesian random effect distribution. Statistica Sinica 2011; 21(3), 1201-1223. PMCID: PMC3870168. 3. Dose finding and dose-schedule finding are critical early steps in the development of drugs that treat cancer. Along with colleagues, I have developed efficient and robust designs for dose-finding and dose- schedule-finding trials that have improved the drug development process. Examples of our proposed designs include the modified toxicity probability interval-based designs, which have been routinely used by practitioners including major pharmaceutical companies in their dose-finding trials. I have also mentored trainees (marked by a * below) in developing other novel and efficient designs for dose- and doseschedule-finding trials. a. Li Y, Bekele BN, Ji Y, Cook JD. Dose-schedule finding in phase I/II clinical trials using a Bayesian isotonic transformation. Statistics in Medicine 2008; 27(24), 4895-4913. PMCID: PMC4562497. b. *Guo B, Li Y. Bayesian designs of phase II oncology trials to select maximum effective dose assuming monotonic dose-response relationship. BMC Medical Research Methodology 14:95, 2014. PMCID: PMC4119476. c. *Guo B, Li Y. Bayesian dose-finding designs for combination of molecularly targeted agents assuming partial stochastic ordering. Statistics in Medicine 2015; 34(5):859-875. PMCID: PMC4359011. d. *Guo B, Li Y, Yuan Y. A dose-schedule-finding design for phase I/II clinical trials. Journal of the Royal Statistical Society, Series C 2016; 65(2):259-272. PMCID: PMC4747255. 4. Along with colleagues, I have developed missing data methods, in particular, nonparametric multiple imputation methods for ignorable missing data. These methods are widely applicable in biomedical studies, where missing data commonly arise. a. Hsu C-H, Li Y, Long Q, Zhao Q, Lance P. Estimation of recurrence of colorectal adenomas with dependent censoring using weighted logistic regression. PLoS One 6(10):e25141, 10/2011. PMCID: PMC3204965. b. Long Q, Hsu CH, Li Y. Doubly robust nonparametric multiple imputation for ignorable missing data. Statistica Sinica 22(1):149-172, 2012. PMCID: PMC3280694. c. Hsu C-H, Long Q, Li Y, Jacobs B. A nonparametric multiple imputation approach for data with missing covariate values with application to colorectal adenoma data. Journal of Biopharmaceutical Statistics 24(3):634-648, 4/2014. PMCID: PMC4353564. d. Hsu C-H, He Y, Li Y, Long Q, Friese R. Doubly robust multiple imputation using kernel-based techniques. Biometrical Journal 2016; 58(3):588-606. [PubMed - in process] Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/yisheng.li.1/bibliography/45331928/public/?sort=date&direction=asce nding. D. Research Support Ongoing Research Support 5 P30 CA016672 40 DePinho (PI) 9/4/1988-6/30/2018 NIH/NCI Cancer Center Support Grant - Biostatistics Shared Resource (BGR) The overarching goal is to improve the standard of patient care, as researchers and clinicians work to eliminate cancer. PID838041 Role: Statistician 172100-30-111870-46 Prokhorov (PI) 6/15/2013-12/31/2017 Centers for Medicare and Medicaid Services (CMS) An evidence-based smoking cessation program for underserved persons living with HIV/AIDS To reduce the morbidity and mortality due to tobacco-related cancers among persons living with HIV/AIDS. FUND111870 Role: Co-Investigator Lopez (PI) 12/12/2013-11/5/2016 MDACC Institutional Research Grant (IRG) A Pilot Study of Oncology Massage to Treat Chemotherapy-Induced Peripheral Neuropathy To evaluate the feasibility and initial efficacy of two treatment schedules (twice weekly for 6 weeks and three times weekly for 4 weeks, versus a control group) of a standardized Swedish massage therapy technique. Role: Co-Investigator DFI Seed Funding Research Program McNeill (PI) 11/1/2014-10/31/2016 UTMDACC Duncan Family Institute Seed Funding Research Program Food Deserts in Houston? Increasing Fruit and Vegetable Consumption to Reduce Cancer Risk To determine the feasibility of recruiting African American families and implementing Brighter Bites program in a Houston area food desert-located church. Role: Co-Investigator 13055845 (PID00000627) Cohen (PI) Gateway for Cancer Research Comprehensive Integrative Oncology Clinical Trial CompLife Study 710177-80-107891 4.22.16 Role: Collaborator 4/1/2015-12/31/2017 127952 Milbury (PI) 7/1/2015-6/30/2017 American Cancer Society (ACS) Couple-based meditation program for lung cancer patients and partners To improve quality of life in cancer patients. PID3238 Role: Co-Investigator 1 R01 HL127260-01 Fagundes (PI) 8/1/2015-4/30/2020 Subaward from Rice University /NHLBI Project Heart: Biobehavioral effects on Cardiovascular Risk for Bereaved Spouses To provide insight into the links between early adversity, social support, depressive symptoms and inflammation in sample of breast cancer survivors. PID3522 Role: Co-Investigator 1U01CA199218-01 Berry (PI) 9/1/2015-8/31/2020 Georgetown University Medical Center Comparative Modeling: Informing Breast Cancer Control Practice and Policy To develop model inputs related to treatment benefits and harms that have been developed in recent years. PID3477 Role: Co-Investigator U01 CA152958 Mandelblatt (PI) 9/1/2015-8/31/2016 Subaward from Georgetown University (NCI) Pilot CISNET - BOLD Task Force Supplement To provide support for analysis of three national datasets that include robust biomarker data and complete follow‐up to support incorporation of biomarker status into AJCC breast cancer staging. PID3361 Role: Co-Investigator 710177-80-107891 Cohen (PI) MDACC - Servan Schrieber Cohen Servan Schrieber Cohen Increase funding for cancer research Role: Statistician 9/1/2015-8/31/2016 Satcher (PI) 9/1/2015-8/31/2017 Cancer Survivorship Research Seed Money Using telemonitoring to optimize the mobility of cancer survivors with skeletal metastases after surgery to preserve limb function To develop customized APPS and imaging technology for mobile devices for remote surveillance of late effects and functional status of cancer survivors after surgery. Role: Co-Investigator 1R21CA191711-01A1 Milbury (PI) 12/28/2015-11/30/2017 NIH/NCI Couple-based meditation program for patients with metastatic lung cancer and their partners Demonstrate the feasibility and initial effectiveness of a couple-based meditation intervention to improve quality of life and symptom burden in patients with metastatic lung cancer.PID3883 Role: Co-Investigator 16634 Garcia (PI) 2/23/2016-2/22/2017 Gateway for Cancer Research Randomized-controlled trial of acupuncture for post-mastectomy pain syndrome To evaluate the use of acupuncture for reducing chronic pain, improving physical function, and improving QOL between three groups of participants experiencing PMPS after breast cancer surgery: active electroacupuncture (EA), sham electroacupuncture (SEA), and waitlist controls (WLC). Role: Co-Investigator Completed Research Support Milbury (PI) 6/1/2015-5/31/2016 MDACC IRG Couple-Based Yoga Program for Glioma Patients and their Partners This investigation will examine the role of a mind-body intervention in improving the health of couples affected by brain tumors. Role: Collaborator CP15990 Hortobagyi (PI) 6/1/2015-5/31/2016 Breast Cancer Foundation Revising AJCC TNM Breast Cancer Staging: Analyzing National Datasets To provide support for analysis of three national datasets that include robust biomarker data and complete follow‐up to support incorporation of biomarker status into AJCC breast cancer staging. PID3504 Role: Co-Investigator 5 R01 CA132636 05 Vidrine (PI) 7/1/2008-5/31/2014 NIH/NCI The influence of HIV disease events/stages on smoking attitudes and behaviors The goal of this project is to explore the relationships among HIV disease events/stages, perceived impact of HIV, attitudes about smoking, and smoking behaviors. Role: Co-Investigator 5 R01 NR011453 05 McNeill (PI) 7/22/2009-12/30/2014 NIH/NINR Social contextual and environmental predictors of PA in sedentary minority adults The study will use survey, qualitative, and state-of-the-science EMA methods to longitudinally and prospectively examine the influence of selected psychosocial, social contextual, and objective and perceived physical environmental factors on self-initiated moderate-intensity physical activity among African Americans and Latinos. Role: Co-Investigator 5 U01 CA152958 05 Mandelblatt (PI) 9/1/2010-8/31/2015 NIH/NCI (Subcontract from Georgetown University) CISNET Comparative Modeling: Informing Breast Cancer Control Practice & Policy To develop model inputs related to treatment benefits and harms that have been developed in recent years. Role: Co-Investigator 5 R01CA148707-04 Cohen (PI) 2/15/2011-1/31/2015 NIH/NCI Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia To improve scientific knowledge regarding the benefits of acupuncture for xerostomia by conducting a multicenter, placebo-controlled, single-blind, phase III clinical trial of acupuncture to prevent xerostomia. Role: Co-Investigator Milbury (PI) 5/1/2014-4/30/2015 MDACC (IRG) Couple-Based Yoga Program for Glioma Patients and their Partners Examine the feasibility of a couple-based yoga program in 40 glioma patients undergoing RT and their partners. Role: Biostatistical Collaborator 1-R01-CA172786-01A1 McNeill (PI) 5/1/2015-4/30/2016 NIH (Subcontract from University of Oklahoma Health Sciences Center) Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System To evaluate the efficacy and cost-effectiveness of a theoretically- and empirically-based "Motivation And Problem-Solving (MAPS) approach - with and without the addition of interactive text , messaging - to promoting and facilitating smoking cessation among cervical cancer survivors in a large, safety net public healthcare system. PID3051 Role: Co-Investigator