IDMC Team

Faculty Biostatisticians by Therapeutic Area

(most experienced first)

Cardilogy/Vascular Disease

Kerry L. Lee, Ph.D.

Michael Pencina, Ph.D.

Hussein Al-Khalidi, Ph.D.

Kevin Anstrom, Ph.D.

Cindy Green, Ph.D.

Yuliya Lokhnygina, Ph.D.

Shein-Chung Chow, Ph.D.

Susan Halabi, Ph.D.

Andrzej Kosinski, Ph.D.

Steven Grambow, Ph.D.

Xiaofei Wang, Ph.D.

Pulmonology

Kevin Anstrom, Ph.D.

Shein-Chung Chow, Ph.D.

Xiaofei Wang, Ph.D.

GI/Hepatology

Steven Grambow, Ph.D.

Hussein Al-Khalidi, Ph.D.

Huiman Barnhart, Ph.D.

Shein-Chung Chow, Ph.D.

Infectious Disease

Hussein Al-Khalidi, Ph.D.

Kerry L. Lee, Ph.D.

Shein-Chung Chow, Ph.D.

Steven Grambow, Ph.D.

Kevin Anstrom, Ph.D.

Neurosciences

Greg Samsa, Ph.D.

Michael Pencina, Ph.D.

Shein-Chung Chow, Ph.D.

Yuliya Lokhnygina, Ph.D.

Oncology

Stephen George, Ph.D.

Xiaofei Wang, Ph.D.

Susan Halabi, Ph.D.

Greg Samsa, Ph.D.

Shein-Chung Chow, Ph.D.

Andrzej Kosinski, Ph.D.

Endocrinology

Shein-Chung Chow, Ph.D.

Michael Pencina, Ph.D.

Nephrology

Kerry L. Lee, Ph.D.

Shein-Chung Chow, Ph.D.

Huiman Barnhart, Ph.D.

Hematology

Cynthia Coffman, Ph.D.

Shein-Chung Chow, Ph.D.

Operational Leadership

Robert Bigelow, PhD

Director of DMC Operations

Dr. 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.  Dr. 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

Director of Biostatistics

Dr. Pencina serves as the Faculty Director of Biostatistics at the DCRI. His expertise/interests include cardiovascular, psychiatry, and pulmonary therapeutic areas as well as event-driven and pragmatic trials. Dr. 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

Dr. 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 Data Solutions for Clinical Trials and Associate Director Biostatistics

Dr. Anstrom is the DCRI’s Director of Data Solutions for Clinical Trials and the Associate Director for Biostatistics. 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

Dr. 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

DMC Trial Experience: Dr. 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.

Dr. Chow is an expert in the area of adaptive trial design including experience in the following applications:

 

Cynthia Coffman, PhD

Dr. 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

Dr. 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

Dr. 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

Dr. 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

Dr. 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

Dr. 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

Kerry Lee, PhD

Dr. Lee has extensive experience supporting and participating on DMC’s in the cardiology/vascular disease therapeutic area.  He is an expert in biostatistics and biostatistical methods surrounding clinical trial design and analysis.

 

DMC Trial Experience

Cardiology/Vascular Disease- 40 trials
Infectious Disease - 3 trials
Nephrology - 3 trials

Yuliya LokhnyginaPhD

Dr. 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 Samas, PhD

Dr. 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

Xiamfei Wang, PhD

Dr. 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