Located on the Harvard Medical Campus, the Department of Biostatistics was one of the first departments in the newly formed Harvard School of Public Health in 1922. Now in its 80th year, the Department comprises 85 students, 57 faculty members, and 22 research associates and fellows. Our size contributes to our ability to address a broad spectrum of biostatistical and public health issues.

Current departmental research on statistical and computing methods for observational studies and clinical trials includes survival analysis, missing-data problems, and causal inference. Other areas of investigation are environmental research (methods for longitudinal studies, analyses with incomplete data, and meta-analysis); statistical aspects of the study of AIDS and cancer; quantitative problems in health-risk analysis, technology assessment, and clinical decision making; statistical methodology in psychiatric research and in genetic studies; Bayesian statistics; statistical computing; statistical genetics and computational biology; and collaborative research activities with biomedical scientists in other Harvard-affiliated institutions.

The Harvard University Biostatistics Working Paper Series presents contributions by our faculty and researchers that rely on the theory and application of statistical science to analyze public health problems.

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Papers from 2022

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Marginal Proportional Hazards Models for Clustered Interval-Censored Data with Time-Dependent Covariates, Kaitlyn Cook, Wenbin Lu, and Rui Wang

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Nonlinear Mixed-Effects Models for HIV Viral Load Trajectories Before and After Antiretroviral Therapy Interruption, Incorporating Left Censoring, Sihaoyu Gao, Lang Wu, Tingting Yu, Roger Kouyos, Huldrych F. Gunthard, and Rui Wang

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On assessing survival benefit of immunotherapy using long-term restricted mean survival time, Miki Horiguchi, Lu Tian, and Hajime Uno

Papers from 2021

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Causal Mediation Analysis for Difference-in-Difference Design and Panel Data, Pei-Hsuan Hsia, An-Shun Tai, Chu-Lan Michael Kao, Yu-Hsuan Lin, and Sheng-Hsuan Lin

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On The Conventional Definition Of Path-Specific Effects - fully mediated interaction with multiple ordered mediators, An-Shun Tai, Le-Hsuan Liao, and Sheng-Hsuan Lin

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Identification And Robust Estimation Of Swapped Direct And Indirect Effects: Mediation Analysis With Unmeasured Mediator–Outcome Confounding And Intermediate Confounding, An-Shun Tai and Sheng-Hsuan Lin

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Causal Mediation Analysis with Multiple Time-Varying Mediators, An-Shun Tai, Sheng-Hsuan Lin, Yu-Cheng Chu, Tsung Yu, Milo A. Puhan, and Tyler VanderWeele

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Ratio and Difference of Average Hazard with Survival Weight: New Measures to Quantify Survival Benefit of New Therapy, HAJIME UNO and MIKI HORIGUCHI

Papers from 2020

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Estimation of Conditional Power for Cluster-Randomized Trials with Interval-Censored Endpoints, Kaitlyn Cook and Rui Wang

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Power calculation for cross-sectional stepped-wedge cluster randomized trials with binary outcomes, Linda J. Harrison and Rui Wang

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Randomization-Based Confidence Intervals for Cluster Randomized Trials, Dustin J. Rabideau and Rui Wang

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Estimating Marginal Hazard Ratios by Simultaneously Using A Set of Propensity Score Models: A Multiply Robust Approach, Di Shu, Peisong Han, Rui Wang, and Sengwee Toh

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Robust inference on effects attributable to mediators: A controlled-direct-effect-based approach for causal effect decomposition with multiple mediators, An-Shun Tai, Yi-Juan Du, and Sheng-Hsuan Lin

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Integrated multiple mediation analysis: A robustness–specificity trade-off in causal structure, An-Shun Tai and Sheng-Hsuan Lin

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Survival mediation analysis with the death-truncated mediator: The completeness of the survival mediation parameter, An-Shun Tai, Chun-An Tsai, and Sheng-Hsuan Lin

Papers from 2019

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Generalized interventional approach for causal mediation analysis with causally ordered multiple mediators, Sheng-Hsuan Lin

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Variance Estimation in Inverse Probability Weighted Cox Models, Di Shu, Jessica G. Young, Sengwee Toh, and Rui Wang

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General approach of causal mediation analysis with causally ordered multiple mediators and survival outcome, An-Shun Tai, Pei-Hsuan Lin, Yen-Tsung Huang, and Sheng-Hsuan Lin

Papers from 2018

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Power Calculation for Cross-Sectional Stepped Wedge Cluster-Randomized Trials with Variable Cluster Sizes, Linda J. Harrison, Tom Chen, and Rui Wang

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Technical Considerations in the Use of the E-value, Tyler J. VanderWeele, Peng Ding, and Maya Mathur

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Cross-sectional HIV Incidence Estimation Accounting for Heterogeneity Across Communities, Yuejia Xu, Oliver B. Laeyendecker, and Rui Wang

Papers from 2017

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Quantifying the totality of treatment effect with multiple event-time observations in the presence of a terminal event from a comparative clinical study, Brian Claggett, Lu Tian, Haoda Fu, Scott D. Solomon, and L. J. Wei

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Studying the Optimal Scheduling for Controlling Prostate Cancer under Intermittent Androgen Suppression, Sunil K. Dhar, Hans R. Chaudhry, Bruce G. Bukiet, Zhiming Ji, Nan Gao, and Thomas W. Findley

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Mediation Analysis for Censored Survival Data under an Accelerated Failure Time Model, Isabel Fulcher, Eric J. Tchetgen Tchetgen, and Paige Williams

Papers from 2016

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Using Validation Data to Adjust the Inverse Probability Weighting Estimator for Misclassified Treatment, Danielle Braun, Corwin Zigler, Francesca Dominici, and Malka Gorfine

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A Cautionary Note on the Effect of Treatment Misclassification on the Average Treatment Effect, Danielle Braun, Corwin Zigler, Malka Gorfine, and Francesca Dominici

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Model Averaged Double Robust Estimation, Matthew Cefalu, Francesca Dominici, Nils D. Arvold MD, and Giovanni Parmigiani

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Leveraging Contact Network Structure in the Design of Cluster Randomized Trials, Guy Harling, Rui Wang, Jukka-Pekka Onnela, and Victor DeGruttola

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The Myth Of Making Inferences For An Overall Treatment Efficacy With Data From Multiple Comparative Studies Via Meta-analysis, Takahiro Hasegawa, Brian Claggett, Lu Tian, Scott D. Solomon, Marc A. Pfeffer, and Lee-Jen Wei

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Robust alternatives to ANCOVA for estimating the treatment effect via a randomized comparative study, Fei Jiang, Lu Tian, Haoda Fu, Takahiro Hasegawa, Marc Alan Pfeffer, and L. J. Wei

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Mediation analysis for a survival outcome with time-varying exposures, mediators, and confounders, Sheng-Hsuan Lin, Jessica G. Young, Roger Logan, and Tyler J. VanderWeele

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Estimation and Inference for the Mediation Proportion, Daniel Nevo, Xiaomei Liao, and Donna Spiegelman

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CRTgeeDR: An R Package for Doubly Robust Generalized Estimating Equations Estimations in Cluster Randomized Trials with Missing Data, Melanie Prague, Rui Wang, and Victor De Gruttola

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Accounting for Interactions and Complex Inter-Subject Dependency in Estimating Treatment Effect in Cluster Randomized Trials with Missing Outcomes, Melanie Prague, Rui Wang, Alisa Stephens, Eric Tchetgen Tchetgen, and Victor DeGruttola

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Efficiency of Two Sample Tests via the t-Mean Survival Time for Analyzing Event Time Observations, Lu Tian, Haoda Fu, Stephen J. Ruberg, Hajime Uno, and LJ Wei

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Moving beyond the conventional stratified analysis to estimate an overall treatment efficacy with the data from a comparative randomized clinical study, Lu Tian, Fei Jiang, Takahiro Hasegawa, Hajime Uno, Marc Alan Pfeffer, and L.J. Wei

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The use of permutation tests for the analysis of parallel and stepped-wedge cluster randomized trials, Rui Wang and Victor DeGruttola

Papers from 2015

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A general framework for diagnosing confounding of time-varying and other joint exposures, John W. Jackson

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Simulation of Semicompeting Risk Survival Data and Estimation Based on Multistate Frailty Model, Fei Jiang and Sebastien Haneuse

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Survival analysis with functions of mis-measured covariate histories: the case of chronic air pollution exposure in relation to mortality in the Nurses' Health Study, Xiaomei Liao, Molin Wang, Jaime E. Hart, Francine Laden, and Donna Spiegelman

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Doubly Robust Estimation of a Marginal Average Effect of Treatment on the Treated With an Instrumental Variable, Lan Liu, Wang Miao, Baoluo Sun, James M. Robins, and Eric J. Tchetgen Tchetgen

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On Varieties of Doubly Robust Estimators Under Missing Not at Random With an Ancillary Variable, Wang Miao and Eric Tchetgen Tchetgen

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Identification and Doubly Robust Estimation of Data Missing Not at Random with an Ancillary Variable, Wang Miao, Eric Tchetgen Tchetgen, and Zhi Geng

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On Partial Identification of the Pure Direct Effect, Caleb Miles, Phyllis Kanki, Seema Meloni, and Eric Tchetgen Tchetgen

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Lepski's Method and Adaptive Estimation of Nonlinear Integral Functionals of Density, Rajarshi Mukherjee, Eric J. Tchetgen Tchetgen, and James M. Robins

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On Simple Relations Between Difference-in-differences and Negative Outcome Control of Unobserved Confounding, Tamar Sofer, David B. Richardson, Elena Colincino, Joel Schwartz, and Eric J. Tchetgen Tchetgen

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Negative Outcome Control for Unobserved Confounding Under a Cox Proportional Hazards Model, Eric J. Tchetgen Tchetgen, Tamar Sofer, and David Richardson

Papers from 2014

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Estimation of the Overall Treatment Effect in the Presence of Interference in Cluster-randomized Trials of Infectious Disease Prevention, Nicole Bohme Carnegie, Rui Wang, and Victor De Gruttola

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Extending Mendelian Risk Prediction Models to Handle Misreported Family History, Danielle Braun, Malka Gorfine, Hormuzd A. Katki, Argyrios Ziogas, Hoda Anton-Culver, and Giovanni Parmigiani

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Nonparametric Adjustment for Measurement Error in Time to Event Data, Danielle Braun, Malka Gorfine, Hormuzd A. Katki, Argyrios Ziogas, and Giovanni Parmigiani

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A Predictive Enrichment Procedure to Identify Potential Responders to a New Therapy for Randomized, Comparative, Controlled Clinical Studies, Junlong Li, Lihui Zhao, Lu Tian, Tianxi Cai, Brian Claggett, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Fernando Ulloa-Montoya, and L. J. Wei

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Likelihood Based Estimation of Logistic Structural Nested Mean Models with an Instrumental Variable, Roland A. Matsouaka and Eric J. Tchetgen Tchetgen

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Quantifying an Adherence Path-Specific Effect of Antiretroviral Therapy in the Nigeria PEPFAR Program, Caleb Miles, Ilya Shpitser, Phyllis Kanki, Seema Meloni, and Eric J. Tchetgen Tchetgen

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Control Function Assisted IPW Estimation with a Secondary Outcome in Case-Control Studies, Tamar Sofer, Marilyn C. Cornelis, Peter Kraft, and Eric J. Tchetgen Tchetgen

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Constrained Bayesian Estimation of Inverse Probability Weights for Nonmonotone Missing Data, BaoLuo Sun and Eric J. Tchetgen Tchetgen

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A Note on the Control Function Approach with an Instrumental Variable and a Binary Outcome, Eric Tchetgen Tchetgen

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A Simple Regression-based Approach to Account for Survival Bias in Birth Outcomes Research, Eric J. Tchetgen Tchetgen, Kelesitse Phiri, and Roger Shapiro

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Instrumental Variable Estimation in a Survival Context, Eric J. Tchetgen Tchetgen, Stefan Walter, Stijn Vansteelandt, Torben Martinussen, and Maria Glymour

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Bounds to Evaluate the Pure/natural Direct Effect without Cross-world Counterfactual Independence, Eric Tchetgen Tchetgen and Kelesitse Phiri

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A General Approach to Detect Gene (G)-environment (E) Additive Interaction Leveraging G-E Independence in Case-control Studies, Eric Tchetgen Tchetgen, Tamar Sofer, and Benedict H.W. Wong

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A unification of mediation and interaction: a four-way decomposition, Tyler J. VanderWeele

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Mediation Analysis with Time-Varying Exposures and Mediators, Tyler J. VanderWeele and Eric Tchetgen Tchetgen

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Generalized Quantile Treatment Effect, Sergio Venturini, Francesca Dominici, and Giovanni Parmigiani

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Predicting the Future Subject's Outcome via an Optimal Stratification Procedure with Baseline Information, Florence H. Yong, Lu Tian, Sheng Yu, Tianxi Cai, and L. J. Wei

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Optimal Bayesian Adaptive Trials when Treatment Efficacy Depends on Biomarkers, Yifan Zhang, Lorenzo Trippa, and Giovanni Parmigiani

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On the Restricted Mean Survival Time Curve Survival Analysis, Lihui Zhao, Brian Claggett, Lu Tian, Hajime Uno, Marc A. Pfeffer, Scott D. Solomon, Lorenzo Trippa, and L. J. Wei

Papers from 2013

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Phylogenetic Linkage Among HIV-infected Village Residents in Botswana: Estimation of Clustering Rates in the Presence of Missing Data, Nicole Bohme Carnegie, Rui Wang, Vladimir Novitsky, and Victor G. DeGruttola

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Efficient Estimation of Risk Ratios From Clustered Binary Data, Matthew Cefalu and Eric Tchetgen Tchetgen

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Simulating Bipartite Networks to Reflect Uncertainty in Local Network Properties, Ravi Goyal, Joseph Blitzstein, and Victor De Gruttola

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A General Regression Framework for a Secondary Outcome in Case-control Studies, Eric J. Tchetgen Tchetgen

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Identification and Estimation of Survivor Average Causal Effects, Eric J. Tchetgen Tchetgen

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Alternative Identification and Inference for the Effect of Treatment on the Treated with an Instrumental Variable, Eric J. Tchetgen Tchetgen and Stijn Vansteelandt

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A General Instrumental Variable Framework for Regression Analysis with Outcome Missing Not at Random, Eric J. Tchetgen Tchetgen and Kathleen Wirth

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On the Restricted Mean Event Time in Survival Analysis, Lu Tian, Lihui Zhao, and L. J. Wei

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A versatile test for equality of two survival functions based on weighted differences of Kaplan-Meier curves, Hajime Uno, Lu Tian, Brian Claggett, and L. J. Wei

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A unification of mediation and interaction, Tyler J. VanderWeele

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On the causal interpretation of race in regressions adjusting for confounding and mediating variables, Tyler J. VanderWeele and Whitney Robinson

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Attributing effects to interactions, Tyler J. VanderWeele and Eric J. Tchetgen Tchetgen

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Sample Size Considerations in the Design of Cluster Randomized Trials of Combination HIV Prevention, Rui Wang, Ravi Goyal, Quanhong Lei, M. Essex, and Victor DeGruttola

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Más-o-menos: A Simple Sign Averaging Method for Discrimination in Genomic Data Analysis, Sihai Dave Zhao, Giovanni Parmigiani, Curtis Huttenhower, and Levi Waldron

Papers from 2012

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Treatment Selections using Risk-benefit Profiles Based on Data from Comparative Randomized Clinical Trials with Multiple Endpoints, Brian Claggett, Lu Tian, Davide Castagno, and L. J. Wei

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Nonparametric Inference for Meta Analysis with Fixed Unknown, Study-specific Parameters, Brian Claggett, Minge Xie, and Lu Tian

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C2BAT: A Novel Method for Association Between Ge- netic Markers and Multiple Phenotypes, Melissa Naylor and Christoph Lange

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Flexible Covariate-adjusted Exact Tests for Randomized Studies, Alisa J. Stephens, Eric J. Tchetgen Tchetgen, and Victor De Gruttola

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Locally Efficient Estimation of Marginal Treatment Effects when Outcomes are Correlated: Is the Prize Worth the Chase?, Alisa J. Stephens, Eric J. Tchetgen Tchetgen, and Victor De Gruttola

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Formulae for Causal Mediation Analysis in an Odds Ratio Context Without a Normality Assumption for the Continuous Mediator, Eric J. Tchetgen Tchetgen

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Inverse Odds Ratio-Weighted Estimation for Causal Mediation Analysis, Eric J. Tchetgen Tchetgen

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Multiple-Robust Estimation of an Odds Ratio Interaction, Eric J. Tchetgen Tchetgen

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On a Closed-form Doubly Robust Estimator of the Adjusted Odds Ratio for a Binary Exposure, Eric J. Tchetgen Tchetgen

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On a Logistic Mixed Model Formulation of a Quadratic Exponential Model for Correlated Binary Outcomes, Eric J. Tchetgen Tchetgen

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A Cautionary Note on Specification of the Correlation Structure in Inverse-Probability-Weighted Estimation for Repeated Measures, Eric J. Tchetgen Tchetgen, M. Maria Glymour, Jennifer Weuve, and James Robins

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Robust Estimation of Pure/Natural Direct Effects with Mediator Measurement Error, Eric J. Tchetgen Tchetgen and Sheng Hsuan Lin

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On Parametrization, Robustness and Sensitivity Analysis in a Marginal Structural Cox Proportional Hazards Model for Point Exposure, Eric J. Tchetgen Tchetgen and James M. Robins

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On Identification of Natural Direct Effects when a Confounder of the Mediator is Directly Affected by Exposure, Eric J. Tchetgen Tchetgen and Tyler J. VanderWeele

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Robustness of Measures of Interaction to Unmeasured Confounding, Eric J. Tchetgen Tchetgen and Tyler J. VanderWeele

Papers from 2011

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Estimating Subject-Specific Treatment Differences for Risk-Benefit Assessment with Competing Risk Event-Time Data, Brian Claggett, Lihui Zhao, Lu Tian, Davide Castagno, and L. J. Wei

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Statistical Properties of the Integrative Correlation Coefficient: a Measure of Cross-study Gene Reproducibility, Leslie Cope and Giovanni Parmigiani

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Multiple Testing of Local Maxima for Detection of Unimodal Peaks in 1D, Armin Schwartzman, Yulia Gavrilov, and Robert J. Adler

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Multiple Testing of Local Maxima for Detection of Peaks in ChIP-Seq Data, Armin Schwartzman, Andrew Jaffe, Yulia Gavrilov, and Clifford A. Meyer

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Estimation of Risk Ratios in Cohort Studies With Common Outcomes: A Simple and Efficient Two-stage Approach, Eric J. Tchetgen