Heather Kopetskie

Senior Director, Biostatistics

Heather Kopetskie

Senior Director, Biostatistics

Heather Kopetskie, Senior Director of Biostatistics, has worked at Rho for over 14 years. Ms. Kopetskie has experience across Phase 1-4 and observational studies in a variety of therapeutic areas. Ms. Kopetskie is skilled in collaborating on protocol development, writing detailed statistical analysis plans, supporting DSMB meetings, analysis of clinical data, writing and reviewing statistical reports and statistical sections of clinical study reports, and collaborating in manuscript development. She also supervises and coordinates daily activities of other statisticians and programmers. Her primary research experience is in transplantation (over 10 years of experience), infectious disease (MRSA, VRE, and HIV), Hepatitis C, central nervous system (Multiple Sclerosis), and autoimmune diseases (Lupus and Type I Diabetes).


Content by Heather Kopetskie

Blog Post

Cellular Therapy Studies: 7 Common Challenges

Cellular therapy has become increasingly-popular largely due to the fact that cells have the ability to carry out many complex functions that drugs cannot. When successful, cellular therapy can result in a more targeted and thus more effective treatment.

Blog Post

Heat Maps for Database Lock

Preparing a database for lock can be a burdensome process and requires coordinated effort from an entire clinical study team. The team must work together to ensure the accuracy and reliability of the data, but with so many sites, subjects, visits, case report forms (CRFs), and data points it can be difficult to stay on top of the entire process.

Heather Kopetski
Blog Post

FDA Guidance on Non-Inferiority Clinical Trials to Establish Effectiveness

In November 2016, the FDA released final guidance  on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.