Colleen Burns
About Colleen Burns
Colleen Burns serves as the Executive Director of Biometrics at Travere Therapeutics, where she has worked since 2018. She possesses extensive experience in biostatistics and regulatory submissions across various therapeutic areas, including obesity, diabetes, and rare diseases.
Work at Travere Therapeutics
Colleen Burns has served as the Executive Director of Biometrics at Travere Therapeutics since 2018. In this role, she oversees biometrics operations and leads a team responsible for statistical analysis, programming, and data management. Her tenure at Travere Therapeutics has spanned six years, during which she has contributed to various projects and initiatives within the organization.
Previous Experience in the Pharmaceutical Industry
Before joining Travere Therapeutics, Colleen Burns held several key positions in the pharmaceutical sector. She worked as Senior Director of Development and Biometrics at Elcelyx Therapeutics Inc. from 2013 to 2018. Prior to that, she served as Senior Director of Biostatistics at Orexigen Therapeutics from 2010 to 2013. Her career also includes a role as Associate Director of Statistics at Amylin Pharmaceuticals from 2004 to 2010, and as Senior Research Scientist at ALZA Corporation from 2000 to 2004.
Education and Expertise
Colleen Burns holds a Bachelor of Science degree in Mathematics from California State University, Fullerton, and a PhD in Statistics from the University of California, Riverside. Her educational background provides a strong foundation for her extensive expertise in biostatistics and biometrics, particularly in the pharmaceutical industry.
Regulatory Submissions and Strategic Partnerships
Colleen Burns has extensive experience in regulatory submissions, including New Drug Applications (NDAs), supplemental NDAs (sNDAs), Marketing Authorization Applications (MAAs), and Premarket Approvals (PMAs). She has participated in regulatory meetings with the FDA and EU health authorities. Additionally, she has strategic partnering experience across various departments, including Clinical Development, Regulatory, Medical Affairs, Pharmacometrics, Safety, and Preclinical/Nonclinical.
Therapeutic Area Experience
Colleen Burns has a diverse therapeutic area experience that includes obesity, diabetes, cardiovascular diseases, pain management, urology, gastrointestinal disorders, ophthalmology, and oncology. She also has experience in rare diseases, specifically in neurology, kidney disease, and genetic bile acid synthesis disorders. This breadth of knowledge enhances her contributions to biometrics and clinical development.