" ... statisticians stay at FDA because their work is valued. Upon joining the Agency I was humbled by the extent to which medical colleagues relied on us for statistical expertise."
-- Dr. Daniel Rubin, Statistician
Q: What opportunities does FDA offer you that you couldn’t get elsewhere
Daniel Rubin: FDA gives me a chance to work on challenging scientific problems that have a real-world public health impact. Since joining FDA after finishing graduate school seven years ago, I have worked on statistical issues related to the design and analysis of clinical trials for antibiotics. Whenever I see news stories about “superbugs” it hits home that the work FDA is doing is affecting lives--including my own--when my grandmother died of a Clostridium difficile infection.
On a day-to-day basis being a statistician at FDA also means getting to think about interesting technical puzzles and perform data detective work.
Q: Why do scientists like you stay at FDA?
DR: I think statisticians stay at FDA because their work is valued. Upon joining the Agency I was humbled by the extent to which medical colleagues relied on us for statistical expertise. Statisticians collaborate in interdisciplinary teams that can comprise clinicians, pharmacologists, microbiologists, toxicologists, and scientists from other disciplines. In an increasingly data-driven world, we can provide value.
Q: How do you use your science degree at FDA?
DR: My doctoral degree is in biostatistics from the University of California, Berkeley. I would say that someone’s specific dissertation topic is less important at FDA than having the training and ability needed to understand the many different statistical issues that can arise in clinical trials. For instance, this can require gaining an understanding of adaptive designs, multiplicity adjustments, survival analysis, and missing data methodology.
Q: How is science conducted at FDA unique from science conducted at the National Institutes of Health, academia, or industry?
DR: Compared to industry, one difference with being a new FDA statistician is that you will likely be working simultaneously on a large number of different drugs and projects. Compared to academia, the most unique aspect of statistical research at FDA is that it is almost entirely motivated by real data and applications. Since joining FDA I have had the chance to collaborate on methodological research projects related to meta-analysis, causal inference, and personalized medicine.