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Dr. Zhiwei Zhang

Mathematical Statistician, Biostatistics Branch


Research Interests

Design and analysis of clinical trials and biomarker studies, causal inference, precision medicine


Selected Publications:

(*Corresponding author)

Zhang Z, Rockette HE (2005). On maximum likelihood estimation in parametric regression with missing covariates. Journal of Statistical Planning and Inference, 134, 206-223.

Zhang Z, Rockette HE (2006). Semiparametric maximum likelihood for missing covariates in parametric regression. Annals of the Institute of Statistical Mathematics, 58, 687-706.

Zhang Z (2006). Non-inferiority testing with a variable margin. Biometrical Journal, 48, 948-965.

Zhang Z (2009). Likelihood-based confidence sets for partially identified parameters. Journal of Statistical Planning and Inference, 139, 696-710.

Zhang Z (2009). Covariate-adjusted putative placebo analysis in active-controlled clinical trials. Statistics in Biopharmaceutical Research, 1, 279-290.

Zhang Z (2010). Profile likelihood and incomplete data. International Statistical Review, 78, 102-116.

Zhang Z, Albert PS (2011). Binary regression analysis with pooled exposure measurements: A regression calibration approach. Biometrics, 67, 636-645.

Zhang Z, Addo OY, Himes JH, Hediger ML, Albert PS, Gollenberg AL, Lee PA, Louis GMB (2011). A two-part model for reference curve estimation subject to a limit of detection. Statistics in Medicine, 30, 1455-1465.

Simons-Morton BG, Ouimet MC, Zhang Z, Lee SE, Klauer SE, Wang J, Albert PS, Dingus TA (2011). Risky driving and crash rates among novice teenagers and their parents. American Journal of Public Health, 101, 2362-2367.

Zhang Z, Albert PS, Simons-Morton B (2012). Marginal analysis of longitudinal count data in long sequences: methods and applications to a driving study. Annals of Applied Statistics, 6, 27-54.

Simons-Morton BG, Zhang Z, Jackson J, Albert PS (2012). Do elevated gravitation force events while driving predict crashes and near crashes? American Journal of Epidemiology, 175, 1075-1079.

Liu A, Liu C, Zhang Z, Albert PS (2012). Optimality of group testing in the presence of misclassification. Biometrika, 99, 245-251.

Zhang Z, Liu A, Lyles RH, Mukherjee B (2012). Logistic regression analysis of biomarker data subject to pooling and dichotomization. Statistics in Medicine, 31, 2473-2484.

Zhang Z, Chen Z, Troendle JF, Zhang J (2012). Causal inference on quantiles with an obstetric application. Biometrics, 68, 697-706.

Zhang Z, Zhang B (2013). A likelihood paradigm for clinical trials (with discussion). Journal of Statistical Theory and Practice, 7, 157-177 (rejoinder: 196-203).

Zhang Z, Kotz RM, Wang C, Ruan S, Ho M (2013). A causal model for joint evaluation of placebo and treatment-specific effects in clinical trials. Biometrics, 69, 318-327.

Kim SD, Chen Z, Zhang Z, Simons-Morton BG, Albert PS (2013). Bayesian hierarchical Poisson regression models: an application to a driving study with kinematic events. Journal of the American Statistical Association, 108, 494-503.

Nie L, Zhang Z*, Rubin DB, Chu J (2013). Calibration of treatment effect size through propensity score ratio reweighting, with application to clinical trials. Annals of Applied Statistics, 7, 1796-1813.

Zhang Z, Wang C, Nie L, Soon G (2013). Assessing the heterogeneity of treatment effects via potential outcomes of individual patients. Applied Statistics, 62, 687-704.

Zhang Z, Nie L, Soon G, Zhang B (2014). Sensitivity analysis in non-inferiority trials with residual inconstancy after covariate adjustment. Applied Statistics, 63, 515-538.

Zhang Z. (2014). Reverse regression: a method for joint analysis of multiple endpoints in randomized clinical trials. Statistica Sinica, 24, 1753-1769.

Zhang Z, Liu C, Kim SD, Liu A (2014). Prevalence estimation subject to misclassification: the mis-substitution bias and some remedies. Statistics in Medicine, 33, 4482-4500.

Zhang Z, Nie L, Soon G, Liu A (2014). The use of covariates and random effects in evaluating predictive biomarkers under a potential outcome framework. Annals of Applied Statistics, 8, 2336-2355.

Zhang Z, Wang C, Troendle JF (2015). Optimizing the order of hypotheses in serial testing of multiple endpoints in clinical trials. Statistics in Medicine, 34, 1467-1482.

Zhou J, Zhang Z, Li Z, Zhang J (2015). Coarsened propensity scores and hybrid estimators for missing data and causal inference. International Statistical Review, 83, 449-471.

Liu W, Zhang Z*, Schroeder RJ, Ho M, Zhang B, Long C, Zhang H, Irony TZ (2016). Joint estimation of treatment and placebo effects in clinical trials with longitudinal blinding assessments. Journal of the American Statistical Association, 111, 538-548.

Zhang Z, Zhou J, Cao W, Zhang J (2016). Causal inference with a quantitative exposure. Statistical Methods in Medical Research, 25, 315-335.

Zhang Z, Nie L, Soon G, Hu Z (2016). New methods for treatment effect calibration, with applications to non-inferiority trials. Biometrics, 72, 20-29.

Zhang Z, Liu W, Zhang B, Tang L, Zhang J (2016). Causal inference with missing exposure information: methods and applications to an obstetric study. Statistical Methods in Medical Research, 25, 2053-2066.

Zhang Z, Qu Y, Zhang B, Nie L, Soon G (2016). Use of auxiliary covariates in estimating a biomarker-adjusted treatment effect model with clinical trial data. Statistical Methods in Medical Research, 25, 2103-2119.

Zhang Z, Chu J, Rahardja D, Zhang H, Tang L (2016). Responder analysis without dichotomization. Journal of Biopharmaceutical Statistics, 26, 1125-1135.

Wang C, Kane R, Levenson M, Kelman J, Wernecke M, Lee J-Y, Kozlowski S, Dekmezian C, Zhang Z, Thompson A, Smith K, Wu Y-T, Wei Y, Chillarige Y, Ryan Q, Worrall C, MaCurdy TE, Graham DJ (2016). Association between changes in CMS reimbursement policy and drug labels for erythrocyte-stimulating agents with outcomes for older patients undergoing hemodialysis covered by fee-for-service Medicare. Journal of the American Medical Association, 176, 1818-1825.

Zhang Z, Li M, Lin M, Soon G, Greene T, Shen C (2017). Subgroup selection in adaptive signature designs of confirmatory clinical trials. Applied Statistics, 66, 345-361.

Zhang Z, Cheon K (2017). Treatment comparison in randomized clinical trials with nonignorable missingness: a reverse regression approach. Statistical Methods in Medical Research, 26, 776-795.

Liu W, Zhang B, Zhang H, Zhang Z* (2017). Likelihood-based methods for evaluating principal surrogacy in augmented vaccine trials. Statistical Methods in Medical Research, 26, 984-996.

Liu W, Pantoja-Galicia N, Zhang B, Kotz RM, Pennello G, Zhang H, Jacob J, Zhang Z* (2017). Generalized linear mixed models for multi-reader multi-case studies of diagnostic tests. Statistical Methods in Medical Research, 26, 1373-1388.

Zhang Z, Ma S, Nie L, Soon G (2017). A quantitative concordance measure for comparing and combining treatment selection markers. International Journal of Biostatistics, 13(1).

Troendle JF, Leifer E, Zhang Z, Yang S, Jerry H (2017). How to control for unmeasured confounding in an observational time-to-event with exposure incidence information: the treatment choice Cox model. Statistics in Medicine, 36, 3654-3669.

Liu W, Zhang Z*, Nie L, Soon G (2017). A case study in personalized medicine: rilpivirine vs. efavirenz for treatment-naïve HIV patients. Journal of the American Statistical Association, 112, 1381-1392.

Zhang Z, Chen R, Soon G, Zhang H (2018). Treatment evaluation for a data-driven subgroup in adaptive enrichment designs of clinical trials. Statistics in Medicine, 37, 1-11.

Batra P, Rafie S, Zhang Z, Singh AV, Bird CE, Sridhar A, Sullivan GJ (2018). An evaluation of the implementation of pharmacist-prescribed hormonal contraceptives in California. Obstetrics and Gynecology, 131, 850-855.

Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA (2019). Impact of an active music therapy intervention on intensive care patients. American Journal of Critical Care, 28, 48-55.

Wu X, Guo X, Zhang Z (2019). The efficacy of smartphone applications for lifestyle modifications in diabetes: systematic review and meta-analyses. Journal of Medical Internet Research – mHealth and uHealth, 7(1):e12297.

Ma S, Zhu L, Zhang Z, Tsai C-L, Carroll RJ (2019). A robust and efficient approach to causal inference based on sparse sufficient dimension reduction. Annals of Statistics, 47(3), 1505-1535.

Zhang Z, Tang L, Liu C, Berger VW (2019). Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials. Clinical Trials, 16, 122-131.

Zhang Z, Ma S (2019). Machine learning methods for leveraging baseline covariate information to improve the efficiency of clinical trials. Statistics in Medicine, 38, 1703-1714.

Zhang Z, Liu C, Ma S, Zhang M (2019). Estimating Mann-Whitney-type causal effects for right-censored survival outcomes. Journal of Causal Inference, 7.

Zhang Z, Ma S, Shen C, Liu C (2019). Estimating Mann-Whitney-type causal effects. International Statistical Review. 87, 3, 514-530.

Zhang Z, Hu Z, Liu C (2019). Estimating the population average treatment effect in observational studies with choice-based sampling. International Journal of Biostatistics. 15(1).

Ma S, Huang J, Zhang Z* (2019). Exploration of heterogeneous treatment effects via concave fusion. International Journal of Biostatistics, 16(1).

Zhang Z, Li W, Zhang H (2020). Efficient estimation of Mann-Whitney-type effect measures for right-censored survival outcomes in randomized clinical trials. Statistics in Biosciences. vol 12, 246-262.

Zhang W, Liu A, Zhang Z, Nansel T, Hakabi S* (2020). Best (but oft-forgotten) practices: sample size and power calculation for a dietary intervention trial with episodically consumed foods. American Journal of Clinical Nutrition, 112(4), 920-925.

Jeske D, Zhang Z, Smith S (2020). Construction, visualization and applications for neutral zone classifiers. Statistical Methods in Medical Research. Vol. 29(5) 1420-1433.

Cappiello L, Zhang Z*, Shen C, Butala NM, Cui X, Yeh RW (2021). Adjusting for population differences using machine learning methods. Applied Statistics, 70(3), 750-769.

Zhang W, Zhang Z*, Krushkal J, Liu A (2021). Group testing can improve the cost-efficiency of prospective-retrospective biomarker studies. BMC Medical Research Methodology, 21, article 55.

Park J, Schwardt NH, Jo JH, Zhang Z, Pillai V, Phang S, Brady SM, Portillo J, MacGibeny MA, Liang H, Pensler M, Soldin SJ, Yanovski JA, Segre JA, Kong HH (2022). Shifts in the skin bacterial and fungal communities of healthy children transitioning through puberty. Journal of Investigative Dermatology, 142, 212-219.

Zhang W, Zhang Z*, Troendle JF, Liu A. Data-adaptive efficient estimation strategies for biomarker studies embedded in randomized trials. Annals of Applied Statistics, in press.

Hu Z, Zhang Z, Follmann D. Assessing treatment effect through compliance score in randomized trials with noncompliance. Annals of Applied Statistics, in press.



Dr. Zhiwei Zhang

Office Address:
Room 5W614
9609 Medical Center Dr
Rockville, MD 20850


Contact Information:
Tel: (240) 276-6787
Fax: (240) 276-7888
Email:zhiwei.zhang@nih.gov