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Gaëlle Romain, PhD, MSc


Contact Information

Gaëlle Romain, PhD, MSc

Mailing Address

  • VAMOS Lab

    789 Howard Avenue

    New Haven, CT 06519

    United States


I am a PhD Biostatistician for the Vascular Medicine Outcomes research program at Yale University School of Medicine. My primary research interest is the study of health outcomes and associated risk factors in cardiovascular disease patient populations. My current research covers the development and application of statistical methods to study mortality and amputation outcomes in patients with peripheral artery disease and critical limb ischemia. In addition, my work examines the relationship between risk factors and patient reported outcomes using national cardiovascular registry databases. My research includes use of descriptive and predictive methodologies and modeling such as time-to-event survival models, linear or logistic regression, and machine learning methods such as random forest predictive models. My background in health outcomes research includes previous work studying mortality or disease recurrence in patients with cancer. I have extensive experience in survival analysis methods to study outcomes, which often involves adjustment for competing risk. I co-led biostatistics analysis and data quality in registry work and tailored competing risk models in cancer and stroke populations at the University of Dijon, France. I am the lead statistician on the VAMOS research lab which Drs. Smolderen and Mena both direct. I have an established track record of analyzing complex vascular outcomes data, specializing in analyzing competing risks, Bayesian statistics, and mixed modeling.

I am currently the lead statistician on the SCOPE-CLI registry, and the 1R21AT012430-01 “Pain Management Strategies, Associated Psychological Variables, and Outcomes in Critical Limb Ischemia” under the HEAL initiative (PIs Mena-Hurtado and Smolderen) and lead statistician for the 1R01HL163640-01A1 “Multi-isotope Hybrid PET/CT Imaging of Peripheral Artery Disease in Diabetes” (PIs Sinusas, Liu, and Smolderen) project, wherein validation methods of peripheral ischemia within current PAD registry work are being executed. The proposed multi-isotope imaging of lower extremity flow and nerve activity developed and applied in this project in conjunction with imaging of calcifications of the arteries will characterize the pathophysiology of nerve dysfunction in PAD and this information may lead to a paradigm change in the evaluation and long-term management of patients with DM and PAD.

Education & Training

  • PhD
    University of Burgundy, Environmental Health Sciences (2019)
  • MSc
    University of Nantes, Clinical Pharmacology and Epidemiological Modeling (2014)
  • Biostatistician
    National Institute of Environmental Health Sciences
  • Biostatistician/Statistical programmer
    Atlanstat, Contract Research Organizations Research and Clinical Trial
  • BSc (Hon)
    Nantes University, Biostatistics and Bioinformatics (2013)
  • Biostatistician/Data Manager
    University Hospital of Nantes
  • BSc
    University Institute of Technology , Statistics and Computer for Health (2012)
  • AA
    Jean Macé Highscool, Bio-analysis and control (2011)


  • Cross-Validation Of Amputation Outcomes Data Elements For The Vascular Quality Initiative's Medicare Linked Registry
    New Orleans, LA, United States 2023
    American College of Cardiology
  • Development of a 30-Day Health Status Prediction Model for High-Risk Transfemoral Carotid Artery Stenting Using a Simple Machine Learning Algorithm
    Chicago, IL, United States 2022
    American Heart Association Scientific Sessions
  • Comparing performances of three cure models including a new model with time-to-cure as a parameter
    Leuven, Flanders, Belgium 2019
    40th Annual Conference of the International Society for Clinical Biostatistics

Departments & Organizations