Curtis Travers leads NAMSA’s Biostatistics team, helping medical device manufacturers accelerate development and achieve regulatory success through clear, strategic, and scientifically robust statistical guidance. In addition to overseeing complex PMA, 510(k), IDE, and De Novo programs, Curtis serves as the primary point of contact for all biostatistics support on NAMSA’s preclinical studies, ensuring seamless integration of statistical planning from early feasibility through clinical translation. He partners with clients to design efficient studies, mitigate risk, and strengthen regulatory submissions while maintaining open, solution‑oriented communication throughout the product development lifecycle.
Curtis brings broad therapeutic expertise—including ophthalmology, cardiology, neuromodulation, orthopedics, vascular interventions, and urology—and is recognized for translating complex statistical methods into practical, actionable insights. Prior to joining NAMSA in 2018, he served as a biostatistician at Emory University School of Medicine and holds an MPH in Epidemiology from Emory University.
CORE COMPETENCIES
- Strategic biostatistical support for regulated (PMA, 510(k), IDE, De Novo, feasibility, pivotal, post‑market) and non‑regulated programs
- Statistical leadership and coordination for NAMSA preclinical studies
- Support for FDA Pre‑Submissions (Q‑Subs) and direct FDA interaction, including preparation of statistical content, responses to FDA feedback, and participation in sponsor–FDA meetings
- Study design optimization, statistical analysis planning, and end‑to‑end execution
- Protocol and CRF development aligned with regulatory expectations
- Sample size justification and randomization schedule creation
- Clear, client‑focused communication of statistical methods and study implications
- SAS programming for TLGs supporting submissions, DSMB reviews, and interim analyses
- Independent validation of datasets, code, and statistical outputs to ensure accuracy
- Authoring and reviewing statistical sections for clinical and regulatory reports
- Presentation of results to DSMBs, investigators, and cross‑functional teams
- SOP development, process improvement, and implementation of internal best practices
RECENT PROJECTS
- Served as statistical lead for a successful PMA submission for a benign prostatic hyperplasia (BPH) treatment, providing analysis strategy and regulatory-facing statistical support
- Led statistical efforts supporting FDA approval of a vascular closure device, including preparation of rigorous responses to regulatory deficiencies
- Directed accelerated statistical analyses to support time‑critical abstract and manuscript submissions, meeting aggressive publication deadlines
- Lead a global Biostatistics team delivering statistical expertise across 100+ clinical studies per year spanning 15+ therapeutic areas
PUBLICATIONS
- Gehrman, P. R., Bartky, E. J., Travers, C., & Lapidus, K. (2024). A fully remote randomized trial of transcranial alternating current stimulation for the acute treatment of major depressive disorder. The Journal of Clinical Psychiatry, 85(2), 54263.
