Statistics and Data Management Center (SDMC)

Mission Statement

The mission of the NRG Oncology Statistics and Data Management Center (SDMC) is to provide expertise for the design, conduct, and analysis of clinical trials and associated research for NRG Oncology by:

Closely collaborating with NRG Oncology leadership to determine the Group's scientific direction and priorities while working integrally with NRG Oncology investigators to design and conduct efficient clinical trials that will yield definitive conclusions.
Providing continuous oversight of trial conduct throughout all stages from concept inception through protocol development, trial monitoring, initial reporting, and publication.
Ensuring quality and timeliness of data with control checks across the lifecycle of trials and periodic audit by well-functioning mechanisms.
Seeking and applying, or developing as needed, innovative statistical designs to meet needs that arise in NRG and throughout the National Clinical Trials Network (NCTN)
Implementing state-of-the-art data management and information technology systems to assure secure, high-quality data collection, maintenance, and curation for additional discovery and data sharing.

SDMC Divisions

The SDMC is comprised of the following four divisions that work collectively to achieve these goals.

Biostatistics Division
- Study design, monitoring, & analysis
- Study progress reports
- Translational research
- Manuscript development
- Methodologic research
- Data sharing & archiving

Data Management Division
- Participant registration & randomization
- Study forms and database development
- Study activation
- Data management and quality control
- Data delinquency monitoring
- Site staff education

Information Technology Division
- IT Infrastructure
- Software development/support
- Study build/database build and support
- Hardware deployment/maintenance
- Network security/maintenance
- Website & Database creation/maintenance
- User support

Quality Assurance and Operational Support Division
- Institutional accrual and data quality performance
- Fiscal management
- Standard Operating Procedures (SOP) maintenance and training
- Site audits & monitoring
- Central review of audit repots
- Regulatory compliance
- Liaison to NCI, FDA, and others

Organizational Structure

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SDMC Leadership

Group Statistician,
Executive Director SDMC

James J. Dignam, PhD

James J. Dignam, Ph.D., has been involved in multi-center clinical trial design, conduct, monitoring, and analysis for over 25 years. He previously served as the Deputy Group Statistician and Co-Principal Investigator for the NRG Oncology SDMC starting in 2014 and was Group Statistician for RTOG from 2009-2014, after working with the NSABP in various capacities from 1989 to 2008. Dr. Dignam is a Professor of Biostatistics in the University of Chicago Public Health Sciences Department and an Investigator in the University of Chicago Comprehensive Cancer Center. His primary areas of statistical methodology research include clinical trial design and interim monitoring, competing risks analysis, hazard function estimation, and time-to-event data modeling.

Deputy Group Statistician,
Senior Deputy Director SDMC

Gregory Yothers, PhD

Greg Yothers, Ph.D., is a co-primary investigator with Dr. Dignam for the NRG Oncology Statistics and Data Management Center (SDMC). He has been involved with clinical trials for cancer research since joining the National Surgical Adjuvant Breast and Bowel Project (NSABP) in 1999. Dr. Yothers is a Research Professor of Biostatistics at the University of Pittsburgh. He serves on the NCI Gastrointestinal Clinical Trials Steering Committee. His primary research interest is the design, implementation, and analysis of phase II and III clinical trials for cancer research. The focus of his methodological research has been the development of statistical methodologies for identifying a subset of a clinical trial population where a treatment is effective.

Deputy Director SDMC,
Leader of Philadelphia SDMC Office

Kathryn Winter, MS

Kathryn A. Winter, M.S., has been involved in multi-center clinical trial design, conduct, monitoring, and analysis for over 25 years, with NRG Oncology from 2014- present and previously with RTOG from 1995-2014. Ms. Winter has worked on trials across many disease sites and is currently the NRG senior statistician responsible for the NRG GI Non-colorectal Cancer subcommittee trials. Ms. Winter serves/served on several NCI and NRG committees and has given many single and series lectures on statistics/ clinical trials at various National Clinical Trials Network (NCTN) cancer centers. Ms. Winter is Senior Director, Statistics at the American College of Radiology (ACR) Center for Research and Innovation (CRI) in Philadelphia, PA.

Deputy Director SDMC,
Leader of Buffalo SDMC Office

Austin Miller, PhD

Austin Miller, Ph.D., is the Associate Head of the Statistics Division of the NRG Statistics and Data Management Center (SDMC) and the Lead Statistician of the NRG Rare Tumor and Ovarian Tumor Subcommittees and is also a voting member of the Gynecologic Cancer Committee. Dr. Miller participates in the NRG Research Strategy Committee concept review meetings and is a reporting statistician on the NRG Data Monitoring Committee. Dr. Miller’s primary appointment is as Director of Biostatistics and Statistical Programming for the Clinical Trial Development Division of the Department of Biostatistics and Bioinformatics at Roswell Park Comprehensive Cancer Center. At Roswell Park, Dr. Miller also serves on the Scientific Review Committee and collaborates on studies run by GOG Partners. Dr. Miller also has a joint appointment at the University at Buffalo Biostatistics Department. His primary research interests include the design and analysis of experimental, clinical and observational studies, and measurement error models.

NCORP SDMC Deputy Director

Stephanie Pugh, PhD

Stephanie L Pugh, Ph.D., has worked in clinical trials research for over 13 years designing, monitoring, and analyzing quality of life and symptom management clinical trials, as well as therapeutic phase II-III brain and prostate cancer trials. In addition to overseeing the NRG NCORP SDMC, she serves as protocol statistician for several NRG Oncology clinical trials. She is an adjunct scholar at the University of Pennsylvania’s Center for Clinical Epidemiology and Biostatistics. Dr. Pugh graduated from the University of Texas at Austin with a BS in Mathematics and received her doctorate in Biostatistics from the University of Pittsburgh.

Head of Biostatistics Division

Mei-Yin Polley, PhD

Mei Polley, Ph.D., has 17 years of experience as a cancer clinical trial biostatistician. Over the span of her career, Dr. Polley has held many influential positions as a statistical advisor including serving on the Federal Advisory Committee of the US Department of Veterans Affairs (VA), the Scientific Committee of American Society of Clinical Oncology (ASCO), and the Scientific Committee of the CNS Clinical Trials conference, among many others. She has also been competitively elected to many national scientific governing or advisory bodies including the NCI/NCTN Steering Committees for trials in lymphoma and head and neck cancer. Dr. Polley is an Associate Professor of Biostatistics in the University of Chicago Public Health Sciences Department. Within NRG Oncology, she also serves as the Co-Chair and Lead Statistician of the Brain Tumor committee. Dr. Polley’s methodological interests include statistical planning, monitoring, analysis, and reporting of all phases of cancer clinical trials, novel group sequential methods for biomarker validation, prognostic and predictive modeling, and design and analysis of biomarker-based clinical trials.

Head of Data Management Division

Elaina Harper, BS

Elaina L. Harper has supported cooperative group data management efforts for over 20 years. Elaina first joined the NSABP Data Management team in 2002 after obtaining a BS degree in Mathematics from the University of Pittsburgh. Over the course of working with the NSABP group through 2014, and since then with NRG Oncology, Elaina has been involved in various areas of data management including the evolution of paper data management to the implementation of an EDC. Experienced in case report form design, CTSU OPEN entry requirements and study configuration in Medidata Rave, Elaina has served on several working groups over the years including the CSC Data Quality Working Group, CSC Standard End Users Working Group, and most recently the NCI Streamlining Clinical Trials Implementation Committee.

Head of Quality Assurance & Operational Support Division

Mary Jo Antonelli, MBA, MHA

Mary Jo Antonelli has over 18 years of NCI Cooperative Group clinical trials experience. Mary Jo began her clinical trials career in 2004 with the NSABP Regulatory Department, transitioned to the SDMC Data Management team in 2005, and most recently joined NRG Quality Assurance in 2020. She has served on numerous CTSU workgroups over the years, and continues to support several ongoing NCTN initiatives. Mary Jo, in her role leading the NRG Quality Assurance Audit Program, supports the NRG Oncology QA subcommittee, as well as the NRG Protocol Support Committee Quality Control & Communication Working Group. Mary Jo holds a Bachelor of Science in chemistry, a Master of Health Administration and an MBA from the University of Pittsburgh.

Head of Information Technology Division

Regis Leonard, MS

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