Heather Kopetskie
Senior Director, Biostatistics
Heather Kopetskie
Senior Director, Biostatistics
Heather Kopetskie, Senior Director of Biostatistics, has worked at Rho for more than 19 years. Ms. Kopetskie provides leadership and oversight for the biostatistics department and utilizes her experience to guide sponsors on the design and analysis of clinical trials. Her experience spans many therapeutic areas with an emphasis on solid organ and cell transplantation along with rare disease (orphan) products.
At Rho, she has supported both federally funded projects and biotech/pharmaceutical companies. During her tenure she has served as the biostatistical functional lead for the Immune Tolerance Network (ITN) Statistical and Data Coordinating Center and the Clinical Trials in Organ Transplantation (CTOT) Statistical and Clinical Coordinating Center overseeing more than 30 studies in the areas of allergy, immunology, and transplantation.
Ms. Kopetskie earned her master’s degree in Biostatistics from UNC-Chapel Hill.
This is what drives Heather:
“I love working with the team members to find solutions to the unique challenges in clinical trials. Our thinking is constantly being challenged and there is always more to learn. Nothing is more rewarding than seeing the work we do impact patient’s lives.”
Content by Heather Kopetskie
Blog Post
Statistical Guidance for COVID-19 Impacted Trials
Clinical trials conducted during the COVID-19 pandemic have been impacted by public health measures to control the virus. In June, the FDA released a guidance on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. We summarized the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.
Blog Post
Site Investigator vs. Sponsor SAE Causality: Are they different?
Causality assessments may differ between the site investigator and sponsor. It is important to understand the difference in assessments to ensure proper reporting and conduct through a trial. To better understand how to handle these situations it’s important to understand the differences.
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.
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.
