Crunching the numbers

Jesse Reynolds hopes his work as a biostatistician contributes to solving health-related problems that could ultimately improve someone’s life.

Jesse Reynolds’ affinity for math and an undergraduate research methods course steered him toward a career in biostatistics. He eventually focused on public health and epidemiological research after earning his master’s degree and working as a data analyst.

Reynolds came to the Yale School of Public Health in 2012 as a biostatistician. As part of the Yale Center for Analytical Studies (YCAS), he oversaw the university’s ClinicalTrials.gov team and was charged with addressing any potential gaps in results reporting in clinical research at Yale. Last year, Reynolds was promoted to assistant director of Applied Biostatistics at the Yale Center for Clinical Investigation (YCCI).

Today, Reynolds and his team serve as a comprehensive resource hub for clinical researchers, providing everything from study design guidance to safety reporting and budget planning support. This work includes continued oversight of the ClinicalTrials.gov system.

What does a biostatistician do?

A biostatistician analyzes and interprets complex biomedical data to solve health-related problems. By studying clinical or survey data, biostatisticians can uncover trends or potential risks in medicine and public health.

I was initially like a biostatistical janitor, cleaning up all the outstanding results and potential gaps in results reporting at Yale for ClinicalTrials.gov. Our team got good at it, so we were asked to manage it. We’ve written compliance policies, and we work with the Institutional Review Board on an ongoing basis.

Our team provides statistical support to Yale investigators, YCCI scholars, and service providers. We participate in larger projects, whether that means reporting to the U.S. Food and Drug Administration (FDA), conducting mandatory safety reporting, or publishing study results. We support the research process and guide our clients on best practices, while also helping researchers and biostatisticians develop and design their questions and studies before they conduct their research.

What is ClinicalTrials.gov?

ClinicalTrials.gov is the largest database in the world that tracks ongoing and completed research studies and their results. At Yale, we assess and verify that studies comply with various regulatory requirements, whether that’s for an FDA or National Institutes of Health (NIH) funding requirement, per their dissemination policies. These activities include assistance in registering studies and providing reminders for annual monitoring throughout the study’s lifespan. When required, we work with teams so that they report results on time.

For publication requirements, we work to ensure studies remain compliant with the standards of the International Committee of Medical Journal Editors (ICMJE) so that study teams are able publish their results in ICMJE journals.

The ClinicalTrials.gov platform isn’t just for researchers. It’s built for the public to access and easily understand the data and results. The quality of information on the platform has improved significantly over the years, and compliance has also gotten better.

How do you and your team gather and analyze data?

Primarily, we use statistical methods to study and hopefully solve health-related problems. We do this by designing studies and analyzing clinical or survey data to look for trends or risks. Then we disseminate our findings through reports and publications.

The standard framework is called PICO: population, intervention, control, and outcome. We start by asking the researchers to explain what they want to do or what they are looking for. Next, we determine what population they wish to study and whether the study will be controlled or involve a comparison. Finally, what is the outcome? With this information, we help them determine the most appropriate analysis.

Our work typically involves someone who needs support for a study, and I help them write a statistical analysis plan based on the type of data they are collecting and what their research question is. Are they looking at a change in something? Do they want to “predict” something, or are they looking to compare one group to another?

What do you find most rewarding about your work?

I’m motivated by how we might contribute to understanding, addressing, or possibly developing ways to treat health issues that could improve people’s lives, and I appreciate the ability to work in a field where we are disseminating information from Yale that isn’t behind a paywall; it’s publicly available.

One of the best experiences I’ve had at Yale is being the person who gets to mentor other people. I’ve been able to see individuals either advance in their careers at Yale or move to other places and do great things.

I have also had the opportunity to work with people across many different research areas, and I now know much more about clinical trial monitoring, project management, and data management as well as managing applications with the FDA for investigational new drugs. I’ve learned so much about how all of this operates, and it really helps me understand my role even more deeply.