IDMC Team

Faculty Biostatisticians by Therapeutic Area

(most experienced first)

Cardilogy/Vascular Disease

Michael Pencina, PhD

Hussein Al-Khalidi, PhD

Kevin Anstrom, PhD

Cindy Green, PhD

Yuliya Lokhnygina, PhD

Shein-Chung Chow, PhD

Susan Halabi, PhD

Andrzej Kosinski, PhD

Steven Grambow, PhD

Xiaofei Wang, PhD

Pulmonology

Kevin Anstrom, PhD

Shein-Chung Chow, PhD

Xiaofei Wang, PhD

GI/Hepatology

Steven Grambow, PhD

Hussein Al-Khalidi, PhD

Huiman Barnhart, PhD

Shein-Chung Chow, PhD

Infectious Disease

Hussein Al-Khalidi, PhD

Shein-Chung Chow, PhD

Steven Grambow, PhD

Kevin Anstrom, PhD

Neurosciences

Greg Samsa, PhD

Michael Pencina, PhD

Shein-Chung Chow, PhD

Yuliya Lokhnygina, PhD

Oncology

Stephen George, PhD

Xiaofei Wang, PhD

Susan Halabi, PhD

Greg Samsa, PhD

Shein-Chung Chow, PhD

Andrzej Kosinski, PhD

Endocrinology

Shein-Chung Chow, PhD

Michael Pencina, PhD

Nephrology

Shein-Chung Chow, PhD

Huiman Barnhart, PhD

Hematology

Cynthia Coffman, PhD

Shein-Chung Chow, PhD

Operational Leadership

Robert Bigelow, PhD

Director of DMC Operations

Robert Bigelow is Director of DMC Operations and has responsibility for the continuous improvement of DMC activities at the DCRI. In this role, he oversees efforts to standardize components of DMC biostatistics support and leads an initiative to identify and train future DMC members. Bigelow currently serves on the Duke Cancer Institute Safety Oversight Committee, responsible for safety and data monitoring for early-phase therapeutic interventional oncology studies.

DMC Trial Experience

Oncology - 25 trials
Cardiology/Vascular Disease - 2 trials
Endocrinology - 1 trial
Immunology  - 1 trials

Executive Leadership

Michael Pencina, PhD

Faculty Associate Director

Michael Pencina serves as the Faculty Associate Director at the DCRI. His expertise/interests include cardiovascular, psychiatry, and pulmonary therapeutic areas as well as event-driven and pragmatic trials. Pencina is also a member of the CTTI Expert Panel on DMC best practices and has co-authored as well as lectured on a number of DMC-related topics.

DMC Trial Experience

Cardiology/Vascular Disease - 15 trials
Neurosciences - 1 trials
Endocrinology - 1 trial

Thought Leadership

Hussein Al-Khalidi, PhD

Hussein Al-Khalidi’s areas of interest/expertise include survival analysis, group sequential analysis, time-to-recurrent/multiple-type events, interim/futility stopping rules, propensity matched analysis, adaptive designs, observational/cluster-randomized studies, pre-clinical studies, continuous-time Markov models, and dose-response modeling.

DMC Trial Experience

Cardiology/Vascular Disease - 12 trials
GI/Hepatology - 3 trials
Infectious Disease - 2 trials
Other- 4 trials

Kevin Anstrom

Kevin Anstrom, PhD

Director of Biostatistics and Director of Data Solutions for Clinical Trials

Kevin Anstrom is the DCRI’s Director of Biostatistics and the Director of Data Solutions for Clinical Trials. His areas of expertise/interest include casual inference, missing data, and inverse probability weighted (IPW) estimation.

DMC Trial Experience

Cardiology/Vascular Disease - 12 trials
Pulmonology - 8 trials
Infectious Disease  - 1 trials

Huiman Barnhart, PhD

Huiman Barnhart’s areas of interest/expertise include methods for assessing reliability/agreement between methods or raters, evaluating performance of new medical diagnostic tests, missing data, correlated categorical data and methods for clinical trials. Her therapeutic area interests are in nephrology, GI/hepatology, cardiology, and endocrinology.

DMC Trial Experience

GI/Hepatology - 1 trial
Nephrology - 1 trial
Neurosciences- 1 trial
MSK/Arthritis/Skin Disease- 1 trial

Shein-Chung Chow, PhD

Shein-Chung Chow has served as a DMC member and an independent monitoring board member on a number of trials covering the majority of therapeutic areas including cardiology/vascular disease, pulmonology, GI/hepatology, infectious disease, neurosciences, oncology, endocrinology, nephrology, and hematology.

Chow is an expert in the area of adaptive trial design with experience in numerous applications.

 

Cynthia Coffman, PhD

Cynthia Coffman’s areas of interest/expertise include collaborative statistical methodology within the field of health services research:

  • Analyzing complicated longitudinal data structures in both randomized controlled trials and observational studies.
  • Analysis methods applied in epidemiology including capture/recapture methodology, joint modeling of survival and disease progression.

DMC Trial Experience

Hematology - 1 trial
MSK/Arthritis - 2 trials
Dermatology  - 1 trials

 
Stephen George, PhD

Stephen George is a biostatistical expert in the field of oncology covering all disease types including breast, colorectal, lung, prostate, and leukemia. He has approximately 30 years of experience as a DMC member on oncology clinical trials. Additional expertise includes:

  • Sample size and study length determinations
  • Sequential procedures
  • Analysis of prognostic or predictive factors in clinical trials

DMC Trial Experience

Oncology - >100

Steve Grambow, PhD

Steve Grambow’s areas of interest/expertise include mobile health interventions in chronic disease, health services research, and statistical education for clinical researchers.

DMC Trial Experience

GI/Hematology - 35 trials
Cardiology/Vascular Disease - 2 trials
Infectious Disease  - 2 trials

 
Cindy Green, PhD

Cindy Green’s primary areas of interest/expertise are cardiovascular safety including QT and exposure response modeling. She has additional experience in pulmonary (lung transplant) and orthopedic surgery studies.


DMC Trial Experience

Cardiology/Vascular Disease - 10 trials
Substance Abuse - 4 trials

Susan Halabi, PhD

Susan Halabi’s interests are in all areas of oncology clinical trials with particular interest in GU cancers (prostate, renal, bladder). She has experience in statistical analysis of biomarker and high dimensional data, as well as development and validation of prognostic and predictive models.

DMC Trial Experience

Oncology - 15 trials
Cardiology/Vascular Disease - 3 trials

 

Andrzej Kosinski, PhD

Amdrzej Kosinski’s areas of interest/expertise include:

  • Statistical methods for assessing performance of medical diagnostic tests
  • Adjustment for misclassification of exposure
  • Clinical trials design (cardiovascular, substance abuse)
  • Analysis of cardiovascular and stroke data
  • Analysis of observational data
  • Meta-analysis

DMC Trial Experience

Cardiology/Vascular Disease - 3 trials
Oncology- 1 trial

Yuliya Lokhnygina, PhD

Yuliya Lokhnygina’s areas of interest/expertise relate to

  • Clinical trials design and centralized statistical monitoring
  • Causal inference (propensity score methods, inverse probability weighted (IPW) estimation, marginal structural models, etc.)
  • Survival analysis

DMC Trial Experience

Cardiology/Vascular Disease - 4 trials
Neurosciences- 1 trial

Greg Samsa, PhD

Greg Samsa’s areas of interest/expertise include:

  • Study design
  • Instrument development
  • Information synthesis
  • Practice improvement
  • Effective communication of statistical results

DMC Trial Experience

Neurosciences- 10 trials
Oncology - 10 trials

 

Xiaofei Wang, PhD

Xiaofei Wang has been the primary statistician for a number phase III oncology trials and has extensive experience conducing statistical analysis, preparing DMC reports, and responding to DMC requests. His areas of expertise/interest include:

  • Semiparametric inference
  • Statistical methods for diagnostic medicine
  • Design and analysis of clinical trials
  • Cancer biomarker discovery
  • Health outcomes research

DMC Trial Experience

Oncology - 20 trials
Cardiology/Vascular Disease -
1 trial
Pulmonology- 1 trial

Highlighted Biostatisticians Supporting DMC Activities

Jeffrey Leimberger, PhD

Principal Statistician

  • More than 24 years of experience working on trials as a biostatistician at the DCRI.

DMC Trial Experience

Cardiology/Vascular Disease - 5 trials
Substance Abuse- 6 trials

Zhen Huang, MS

Principal Statistician

  • More than 19 years of experience with clinical trials with 12 years of experience as a biostatistician at the DCRI.
  • Instrumental in the development of DMC standardization at the DCRI.
  • Serves as a DMC support mentor/consultant to statistical teams at other academic institutions.

DMC Trial Experience

Cardiology/Vascular Disease - 4 trials
Neurosciences - 4 trials

Dianne Gallup, MS

Principal Statistician

  • More than 24 years of experience supporting clinical trials with 17 years of experience as a biostatistician at the DCRI.

DMC Trial Experience

Cardiology/Vascular Disease - 3 trials
Infectious Disease- 1 trial
Immunology - 1 trial