Cynthia Girman

I am a very driven person, and throughout my 45-year career, I was always pursuing more and more. I was very active in the methodology space and in the real-world evidence for regulatory purposes space, which gave me a lot of visibility for the companies I worked for and within the professional societies. I organized symposia, spoke at conferences, moderated sessions, and even delivered a plenary talk at one annual meeting. I also served on the methodology committee of PCORI for 11 years, always maintaining a focus on improving methods and study design. I guess my workaholic attitude and my constant drive to improve methodology and study design in pharmaceutical research is what I would attribute my success to. However, I now know that true accomplishment is not about how much you achieve in your job, what accolades you have, how many publications you have, or how much money you make. It's all about how at peace you feel, how much love you have, and how much you give to others.

Professionally, the best advice I received was to tell a story. I think storytelling is what we should be doing with statistical reports, epidemiology reports, and reports for regulators. It's not just about presenting facts - we need to tell a story because that's what conveys what the data are really saying. Personally, the most meaningful advice came from my son after he died, when we were writing the book together. He said, 'Don't let life just happen to you. Make life happen for you.' He repeated this to me because we all tend to just get up and go through the routines all day long and then collapse into bed - that's letting life happen to us. But we need to grasp it, we need to make things happen for us, we need to make the life we want, and we need to do the things we enjoy. It's your life, it's not anybody else's life.

I would say stay true to yourself, and stay true to what you know is the right method and the right design to use, and don't let anybody talk you out of it. In consulting and in pharma, it's always a negotiation with the people who are funding the trial or study about the specific methodology and study design being used. We, as biostatisticians and epidemiologists, need to make sure that they understand the flaws of certain approaches and the bias that can creep in with certain approaches. We should stick to what we know is the better way to do things, as opposed to giving in to doing it in a way that introduces a lot of bias. As a consultant and expert in the field, it takes less convincing than when you're working for a company - companies often believe the consultants they bring in more than they believe their own employees, even though you may be an expert yourself.

The biggest challenge in my field is that it's evolving so fast. The FDA is changing things constantly - it seems like almost daily, but at least weekly and monthly - putting out new guidances and changing the rules. For example, they went from requiring two well-controlled randomized clinical trials for approval to requiring one with confirmatory evidence, which is a huge change. AI is also really changing the way everybody works. I can't trust AI for deliverables for my clients because AI truly hallucinates a lot - it makes up references and makes up data, so we have to be very careful. I use it daily in my personal life for things like getting organized or creating tables, but I don't use it for deep research from a medical point of view because I don't trust it. For regulatory-related or publication-related work, we have to do so much checking of AI after we use it that it actually takes more time. Our clients are using AI when they shouldn't and not using it when they should, so things are really evolving. We also have to be careful about confidentiality agreements with our clients - if we use AI that learns from the information we're giving it, we could breach those contracts. AI is improving and our prompting is improving, but we're not quite there yet.

Collaboration is the most important value to me in my work and personal life. People look to me as a leader, but I consider myself a collaborator because that's how I treat everyone that works with me. I don't treat them like an employer-employee relationship, and I never have, because we're all a team working together to accomplish some goal or project. When you do that, I really think you get the most out of people because they want to work and they want to achieve as a team, as opposed to being told what to do. It's a completely different feeling in your work life when you're collaborating with your boss as opposed to him or her telling you what to do. My business model in the consulting firm I run reflects this - I bring people in as collaborating consultants with no hierarchy. They all come in as contract employees, they're all part-time, they're all remote, and it's basically a network of expert consultants that are collaborating. We form a team when we get a project from pharma to consult on. I hope that I bring that collaborative spirit over to our marriage as well, and I think we are very much partners.