"I really enjoy the knowledge-sharing among scientists from the many different scientific disciplines we call on at FDA to do our work. Everyone comes together to ensure that the best regulatory decisions are made to protect public health."
Wioletta Szeszel-Fedorowicz, PhD Lead Mathematical Statistician, Center for Tobacco Products

 

Q: What opportunities does FDA offer you that you couldn’t get elsewhere?

Viola Szeszel-Fedorowicz: FDA offers me the unique opportunity to understand the importance of the regulatory process in protecting public health and safety. Our mission is to make sure that FDA-regulated products such as medical products, food, and cosmetics are safe and effective. I work in FDA’s Center for Tobacco Products (CTP) and our mission is of course different. CTP's mission is to make tobacco-related death and disease part of America's past, not America's future, and, by doing so, ensure a healthier life for every family.

FDA’s vital role in overseeing the safety of the products it regulates cannot be overstated. In my opinion, there is no more important undertaking than shielding public from the risk of unintended consequences associated with the use of its regulated products. At FDA I have the chance to see how our experts from different scientific disciplines work together to make the best, science- and data-driven decisions. I like seeing how my work translates quickly into regulatory action and has an immediate effect on the public health. I am proud to be part of FDA, an agency that is associated with trust and renowned for the quality of its work. Additionally, FDA’s collaborative environment and many opportunities for professional training supports my professional growth. I have never worked in an organization that has provided as many growth opportunities as FDA.

Q: Why do scientists like you stay at FDA?

VS: At FDA, I work as a lead mathematical statistician. Since FDA uses a data-driven approach to its regulatory process, it’s really a perfect fit for statisticians like myself. And because FDA’s regulatory decisions translate into public safety and health, it must consider all possible factors and their effect on everyone. So statisticians are a vital part of the agency because using data, simulations, and predictive modeling helps FDA explore different regulatory scenarios and their impact on populations over the years.

As a workplace, FDA gives statisticians the opportunity to work with diverse statistical methods and variety of data sources, like complex surveys and observational and experimental studies. I think that’s why we statisticians love to work at FDA. We enjoy the variety of our assignments and can use innovative statistical methods to support the agency’s regulatory process with the aim of keeping the public safe.

Q: How do you use your science degree at FDA?

VS: I have a PhD in Organic Chemistry and MSc in Statistics. My postdoctoral training was in molecular biology, studying gene expression. Currently, I work in CTP, which regulates the manufacturing and marketing of tobacco products, products that, unlike the other products FDA regulates, are associated with both acute and chronic health hazards. Studying chronic health hazards is very challenging because it takes a long exposure to the product to see the negative health effects. As a statistician, I work with data, supporting different scientific disciplines, making sure to use all available data, and the best statistical methods in support of FDA regulatory decisions. My PhD degree in organic chemistry and postdoctoral experience has helped me tremendously in understanding the chemical composition and toxicological profile of tobacco products and their effects on human health, which can be measured by several biomarkers.

Q: How is science conducted at FDA unique from science conducted at the National Institutes of Health, academia, or industry?

VS: FDA decisions need to be scientifically justified and the science we use at FDA must have real-life application. Compared with academia, science conducted at FDA translates quickly into actions. FDA scientists are exposed to multiple facts of a project within a short time span and work on multiple projects concurrently. FDA science projects are conducted in multidisciplinary teams, bringing together different perspectives and expertise to ensure public safety. I really enjoy the knowledge-sharing among scientists from the many different scientific disciplines we call on at FDA to do our work. Everyone comes together to ensure that the best regulatory decisions are made to protect public health.