Stefanie Busgang, MPH

Stefanie Busgang is a Senior Biostatistician with nearly a decade of experience supporting clinical research, with a strong focus on medical devices, in vitro diagnostics (IVD), and regulated clinical studies. Her expertise spans neurology, peripheral vascular devices, urology stents, wound care devices, and IVD clinical chemistry and analytical methods. She provides comprehensive statistical support across the clinical lifecycle, including study design, sample size calculations, statistical analysis plans (SAPs), interim and final analyses, and results reporting.

In her role, Stefanie develops and executes statistical analyses for regulatory submissions, Data Safety Monitoring Board (DSMB) meetings, annual progress reports, and peer-reviewed publications. She routinely programs tables, listings, and figures (TLFs) using SAS and validates datasets through independent coding and quality review. Stefanie works closely with Sponsors, clinicians, and physicians to clearly explain statistical methodologies and ensure alignment with study objectives and regulatory expectations, including feedback from the U.S. Food and Drug Administration (FDA).

Prior to joining NAMSA, Stefanie served as a Biostatistician at the Icahn School of Medicine at Mount Sinai, supporting investigator-initiated and federally funded clinical research. She holds a Master of Public Health (MPH) in Epidemiology from Columbia University’s Mailman School of Public Health and a Bachelor of Arts in Neuroscience from Johns Hopkins University.

CORE COMPETENCIES

• Provide statistical support to clients including abstracts, publications, and presentations
• Write statistical analysis plans and execute analyses as described
• Review and support clinical study protocol
• Calculate sample sizes for a range of study designs and create randomization schedules
• Communicate with clients and physicians to provide explanation of statistical techniques
• Write SAS programs to create tables, listings, and graphs for regulatory submissions, • DSMB meetings, interim analysis, publications, and other reporting needs
• Validate reports and datasets by independent coding or code and log review
• Write and review statistical analyses and results sections for publications and reports
• Summarize and present results to DSMB in quarterly meetings

RECENT PROJECTS

• Provided statistical leadership for neurology and vascular medical device studies, including SAP development, interim analyses, and DSMB presentations
• Supported IVD clinical studies by programming and validating TLFs for regulatory reporting and peer-reviewed publications
• Collaborated with Sponsors and clinicians to design statistically robust clinical protocols aligned with FDA and ISO requirements

PUBLICATIONS

• Jain, A. K., Busgang, S. A., Gennings, C., Yates, K. P., Schwimmer, J. B., Rosenthal, P., … & Vos, M. B. (2024). Environmental toxicants modulate disease severity in pediatric metabolic dysfunction‐associated steatohepatitis. Journal of pediatric gastroenterology and nutrition, 79(5), 943-953.
• Hauptman, M., Jackson-Browne, M. S., Busgang, S., Andra, S. S., Patti, M. A., Henderson, N. B., … & Phipatanakul, W. (2024). Urinary biomarkers of environmental exposures and asthma morbidity in a school inner city asthma study. International journal of hygiene and environmental health, 262, 114430.
• Leroue, M. K., Williamson, K. M., Curtin, P. C., Sontag, M. K., Wagner, B. D., Ambroggio, L., … Busgang, S.A., & Mourani, P. M. (2023). Tobacco smoke exposure, the lower airways microbiome and outcomes of ventilated children. Pediatric research, 94(2), 660-667.
• Busgang, S. A., Malin, A. J., & Gennings, C. (2022). My Nutrition Index: A method for measuring optimal daily nutrient intake. BMC nutrition, 8(1), 1-12.
• Malin, A. J., Busgang, S. A., Garcia, J. C., Bose, S., & Sanders, A. P. (2022). Fluoride Exposure and Age of Menarche: Potential Differences Among Adolescent Girls and Women in the United States. Exposure and Health, 14(3), 733-742.
• Bennett, D. H., Busgang, S. A., Kannan, K., Parsons, P. J., Takazawa, M., Palmer, C. D., … & Hertz-Picciotto, I. (2022). Environmental exposures to pesticides, phthalates, phenols and trace elements are associated with neurodevelopment in the CHARGE study. Environment international, 161, 107075.
• Schmidt, R. J., Liang, D., Busgang, S. A., Curtin, P., & Giulivi, C. (2021). Maternal Plasma Metabolic Profile Demarcates a Role for Neuroinflammation in Non-Typical Development of Children. Metabolites, 11(8), 545.
• Stroustrup, A., Bragg, J. B., Busgang, S. A., Andra, S. S., Curtin, P., Spear, E. A., … & Gennings, C. (2020). Sources of clinically significant neonatal intensive care unit phthalate exposure. Journal of exposure science & environmental epidemiology, 30(1), 137-148.
• Barkoski, J. M., Busgang, S. A., Bixby, M., Bennett, D., Schmidt, R. J., Barr, D. B., … & Hertz-Picciotto, I. (2019). Prenatal phenol and paraben exposures in relation to child neurodevelopment including autism spectrum disorders in the MARBLES study. Environmental research, 179, 108719
• Malin, A. J., Lesseur, C., Busgang, S. A., Curtin, P., Wright, R. O., & Sanders, A. P. (2019). Fluoride exposure and kidney and liver function among adolescents in the United States: NHANES, 2013–2016. Environment international, 132, 105012.
• Sanders, A. P., Mazzella, M. J., Malin, A. J., Hair, G. M., Busgang, S. A., Saland, J. M., & Curtin, P. (2019). Combined exposure to lead, cadmium, mercury, and arsenic and kidney health in adolescents age 12–19 in NHANES 2009– 2014. Environment international, 131, 104993.
• Malin, A. J., Busgang, S. A., Cantoral, A. J., Svensson, K., Orjuela, M. A., Pantic, I., … & Gennings, C. (2018). Quality of prenatal and childhood diet predicts neurodevelopmental outcomes among children in Mexico City. Nutrients, 10(8),1093.