The APDC Biostatistical & Trial Design Core provides comprehensive statistical consulting and trial design expertise to innovators in the pediatric space towards producing sound, statistically-valid study designs and analyses that will lead to quality research, development and testing associated with the development and deployment of pediatric devices.
Services Provided
- Clinical Trial Design
- Power and Sample Size Estimation
- Experimental Design
- Randomization Schematics
- Data Management
- Data Modeling and Analysis
- Database Designs
- Customized Graphs and Tables
- Results Interpretation
- Statistical Analysis Plans
Our Team
Traci Leong, PhD Dr. Leong is the lead biostatistician for the APDC Biostatistics Core and is a Research Assistant Professor of Biostatistics and Bioinformatics in the Emory Rollins School of Public Health. Dr. Leong has longstanding collaborations with research faculty in the Emory Department of Pediatrics and Children’s Healthcare of Atlanta. She has collaborated actively for more than 10 years on pediatric related projects in the fields of oncology, cardiology, nephrology and emergency medicine. She is the author of 50 articles in statistics journals such as Statistics in Medicine, Journal of the Royal Statistical, Society and Applied Statistics as well as medical journals such as Cancer, Blood and Circulation. Dr. Leong’s expertise in clinical trials and her familiarity with pediatric research makes her especially suited to lead this biostatistics core.
Andi L. Shane, MD, MPH, MSc Dr. Shane is an Associate Professor in the Emory Dept of Pediatrics and the Clinical Trial Advisor in the APDC Biostatistics & Clinical Trial Design Core. Dr. Shane has 15 years of experience in the design and conduct of clinical research towards improving health outcomes in children. She has served as a site principal investigator on multi-site studies and has independent funding for her own investigator-initiated clinical trials. With a Master’s of Science in Clinical Research and her demonstrated ability to mentor, guide and advise others on their own research endeavors, Dr. Shane provides essential input and expertise as our device projects enter the clinical testing phase of development. Dr. Shane also works closely with the Biostatisticians in this core to ensure all clinical trials are powered appropriately and that data collection methodology has been well designed and defined.
Courtney McCracken, PhD Dr. McCracken serves as a Senior Biostatistician for the APDC Biostatistics Core. Throughout her academic career, she has collaborated on more than 150 pediatric projects and has co-authored numerous manuscripts in journals including Pediatric Radiology, The Journal of Rheumatology, Pediatric Emergency Care, The Journal of Pediatric Orthopedics, and Pediatric Nephrology. Her statistical research interests include analysis of left-censored data, nonparametric methods, analysis of rare events in clinical trials and experimental studies, and healthcare analytics.
Scott Gillespie, MS Mr. Gillespie serves as a Biostatistician for the APDC Biostatistics Core, and has collaborated on over 40 pediatric research projects to date. His research interests include health informatics, data visualization, bootstrapping methodology, and generalized linear modeling.