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Karen Chiswell

Statistical Scientist
Duke Clinical Research Institute
P.O. Box 17969, DUMC # 3850, Durham, NC 27715
Durham Center, 300 West Morgan Street, Durham, NC 27701

Overview


Ph.D., North Carolina State University - 2007

I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning. 

Current Appointments & Affiliations


Recent Publications


Neonatal outcomes of pregnancy in women with congenital heart disease.

Journal Article Am Heart J · January 2026 BACKGROUND: Infants born to women with congenital heart disease (CHD) are at increased risk for adverse outcomes compared with the general population. There are few large, contemporary studies examining the relationship between CHD severity, maternal risk ... Full text Link to item Cite

Comorbidity and Multimorbidity in Adults With Congenital Heart Disease: Findings From a Multi-Site Population-Based Study.

Journal Article Birth Defects Res · August 2025 BACKGROUND: Survival of individuals with congenital heart disease (CHD) has improved, leading to a growing and aging population of adults living with these conditions. Over their lifetime, they often face an array of comorbidities that affect outcomes and ... Full text Link to item Cite
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Recent Grants


The North Carolina Congenital Heart Disease Surveillance Network

Public ServiceSenior Statistician · Awarded by Centers for Disease Control and Prevention · 2024 - 2029

Increasing the Quality and Efficiency of Clinical Trials (U18)

ResearchStatistician · Awarded by Food and Drug Administration · 2014 - 2029

Pharmacokinetic and pharmacodynamic study of montelukast in premature infants with BPD (PRISM)

ResearchStatistical Investigator · Awarded by National Institutes of Health · 2023 - 2028

View All Grants