With the recent arrival of a SARS-CoV-2 vaccine, Helen Parise, ScD, a biostatistician and clinical trials consultant, has received a lot of questions about medical research. “I have never been asked more questions about clinical trials as I have in the past year. People want to understand these vaccine trials. But seeing the effect of a well-designed trial and how it can speed up something like delivering a vaccine to the world during a time like this is exactly why I love my job.”
Parise joins Yale Cardiovascular Medicine with two decades of experience designing, implementing, and analyzing clinical research. In her role, she will direct the new Cardiovascular Medicine Clinical Research Analytics Group.
A biostatistician helps investigators form research questions that can be measured, which ultimately leads to more successful clinical research studies. Biostatisticians also develop a statistical analysis plan to measure, test, and interpret the results.
For Parise, biostatistics was a natural choice. “I’ve always enjoyed puzzles and games and I look at every new project or trial like a big puzzle that we all try to piece together.” She became interested in statistics after taking an econometrics class at the Rensselaer Polytechnic Institute. This led her to pursue a master’s degree at the University of Massachusetts and a doctorate degree in biostatistics at the Harvard T.C. Chan School of Public Health in 1999.
She decided to focus on cardiovascular disease after working with the Framingham Heart Study investigations at Boston University and one of the earliest clinical studies on transcatheter valve implants. More recently, she collaborated with Yale researchers on the Neuro-TAVI Trial. “I find it's important for biostatisticians to understand the science to be able to communicate effectively, to help refine endpoints, and to collect and analyze the data in a meaningful way.”
Biostatistics and clinical trial design
When asked what aspect of biostatistics she enjoys most Parise said collaboration. “I am looking forward to exploiting the synergy that a good biostatistics core can add to a research program. I am faced with new challenging research questions all the time that then lead to interesting methodological questions, she added. “I am also looking forward to providing a resource that becomes a seamless part of the Cardiovascular Medicine team.”
The advent of big data and improvements in technology have made it easier and, in some cases, more difficult for investigators. “It's an overwhelming amount of data that wasn't available ten years ago. The computing resources to handle that kind of data weren't available in the way that they are now. I can analyze data on my laptop that I would have needed a server for twenty years ago. For example, there are various forms of claims data that people are mining for various research questions. That also has its own issues with coding. How do you get the variables out of it that you really want to look at and ensure their veracity?”
Statistical training for medical students is an added concern. Parise will run biostatistics seminars for fellows, trainees, or physicians who might be interested in the statistical aspects of cardiovascular research. The material will address how to synthesize distinct types of data, interpreting P values, and how to navigate challenging situations in clinical trials, such as patients who are lost to follow-up. “I don’t want anyone to feel like what we do as biostatisticians is a big black box.”
Outside of work, Parise enjoys live music, comedy shows, playing golf, and cheering on Philadelphia sport teams.