It is Never too Early to Think About Statistical Leadership
Richard C. Zink, JMP Statistical Discovery LLC
Author’s note: Meijing Wu kindly asked me to write this article shortly before her passing; it is dedicated in her memory.
Highlights
Discover why mastering leadership skills is just as crucial for statisticians as their technical expertise, especially in multidisciplinary settings.
Learn why effectively conveying complex statistical concepts to those with minimal math backgrounds can improve decision-making and career growth.
Explore the importance of developing leadership skills early in your career to thrive in the evolving landscape of statistical science.
Statisticians and data scientists occupy a unique space on a multidisciplinary team. So much so, that it may often feel like a salmon swimming upstream against the current produced by everyone else. Teams want to move fast and meet deadlines, but we know firsthand that every decision, even seemingly innocuous ones, can have major implications and consequences for all downstream activities. This is especially true for clinical trials: large, exceptionally expensive experiments of human beings that often take several months or years to complete the following activities: developing the protocol, designing and testing the database, conducting the study, collecting the data, producing the final analysis, and authoring the final study report. The team does their utmost to produce the best possible product at each stage, but without fail, multiple changes often occur over the course of a study. While changes can create headaches for individual groups, statisticians need to be aware of the entirety of the process, since changes can, and likely will, affect the final analysis. In the worst case scenario, a modified protocol triggers modifications to an electronic data capture system and the underlying raw data, which triggers modifications to SDTM programs, which triggers modifications to ADaM programs, which triggers modifications to programs for tables, figures, and listings. That is a lot of places in need of revision, and plenty of opportunity for things to go wrong. Every passing day is one fewer day prior to database lock to get things in their proper place, much less rethinking, revising, and revalidating the analysis. It is no wonder that SOPs and process improvement are so important in medical product development - it is extraordinarily complex, and there is so much at stake!
Have you ever read a protocol and thought to yourself “there is NO WAY a statistician has reviewed this”? Even sections such as Inclusion and Exclusion Criteria, Study Endpoints, or Study Conduct can be written in a manner so vague or inconsistent that it is unsurprising that protocols are often in need of amendments. When asked to provide the Statistics Section to protocols, I started at page 1, added comments throughout, and more often than not, found major issues that required discussion by the team before I could even begin to write text describing an appropriate statistical methodology and the accompanying summary tables. When team members grew frustrated with my changes and suggestions, especially since they believed they were near the end of protocol development, my response was to include me earlier in the process. It did not take long for this to start happening, and it resulted in fewer hiccups down the road. The take-home message is this: though the analysis comes at the end of the process, the team cannot leave the statistician out of protocol development until the last minute. Unfortunately, it is often up to the statistician to communicate this message.
I am also a big believer in finalizing the statistical analysis plan (SAP) as early as possible in the conduct of the study; I would often have a draft available while the database was being produced and would strive to get it signed off as early as possible. Why go to such extraordinary lengths?
It gets everyone thinking about the analysis early, especially while the protocol is fresh in their minds.
It ensures that the data required to perform the final analysis are collected in an appropriate manner in the study database.
It makes the rest of the study team less likely to change the analysis since the SAP has already been signed off.
Have you ever been in a position where individuals dither finalizing the SAP? Many people make the claim that the SAP needs to be signed prior to database lock and will delay in finalizing the document. While this is absolutely true, this represents the worst case scenario! If the methodology and analyses and assumptions are changing up until a few weeks before database lock, the quality of the analysis suffers, the team producing the analysis suffers, and the timelines often suffer. Like the example above in being able to predict with near certainty whether a statistician was involved in the writing of the protocol, it is just as easy to predict those instances where the SAP was finalized just prior to database lock. In these instances, the database lock will be chaos, topline will be chaos, and the statisticians and statistical programmers will be miserable. The take-home message is this: SAPs need to be finalized sooner. If the argument against finalizing a SAP early is that the “protocol is constantly changing through amendments”, this can be addressed through improving the quality of the original protocol (Hint! Include a statistician from the start.) Otherwise, the statistician needs to adjust the team’s expectations given the disruption of downstream processes.
Hopefully these two examples highlight a very important point: Statisticians need to be leaders. Full stop.
Non-statisticians may not recognize the importance of our unique skill set, even when it comes to the seemingly non-statistical aspects of multidisciplinary work.
Non-statisticians may not recognize the huge implications minor decisions may have on the final analysis.
Non-statisticians may not know what data are needed to conduct an appropriate analysis.
So again, statisticians need to be leaders. We need to communicate. We need to build trust through developing and nurturing relationships with key members of the team. Then, and only then, will we be able to influence others and the direction of our collaborations. Unfortunately, much of our education and training focuses on technical prowess, and less so on leadership, communication, and other interpersonal skills.
The good news is that anyone at any level can be a leader! It can be as easy as moving from the corner of the room to the conference table and being actively engaged in the ongoing discussion. Or you can begin your leadership journey by raising your hand when someone asks for a volunteer. Or you can look for opportunities to simply “make things better”. Consider the important skills statisticians generally already possess:
Organized
Methodical
Thoughtful
Precise
Forward-thinking, with plans for contingencies
Philomathic
Data-driven
These are critical skills for any leader to be effective!
Leadership begins with small steps. For example, sharing knowledge and expertise through presentations at conferences, workshops, or webinars, or writing scientific articles, book chapters, or software elevates your status among your peers. Consider opportunities to engage with non-statistical members of the team by helping them understand statistical concepts (using everyday language!) or offering assistance using your unique blend of skills. Developing or chairing sessions, serving as a referee for a scientific journal, or volunteering for activities for a Section or Chapter of the American Statistical Association (ASA) are excellent ways to build your network and develop an intuition for how to “get things done”. These small opportunities will inevitably lead to larger opportunities: leading major ASA initiatives; serving as a Chapter, Section, or ASA officer; teaching short courses at major conferences; leading scientific working groups; chairing conferences, serving as an editor for a scientific journal; or leading biometrics departments. But even if you have no interest in pursuing major leadership activities, leadership skills will benefit you in performing your day-to-day work as part of a multidisciplinary team. Statisticians represent a very unique and distinct point of view, so we need to make ourselves heard!
One does not wake up a leader. And attending a single course or reading a single book will not make you a leader, either. Like any other set of skills, leadership takes time and practice to grow and develop. Some things to consider:
Get involved with the ASA to develop leadership skills, broaden your network, and support the statistics discipline.
Exhibiting leadership before you have “the title” makes it possible to get “the title”. And its okay if you have no interest in “the title” – leadership skills are useful at any level.
Your knowledge and technical expertise are not particularly useful if you cannot effectively communicate your ideas and convince others to consider implementing them in practice.
Identify a mentor or peer group to discuss professional challenges and identify potential solutions.
Stretch your boundaries by becoming more comfortable with the uncomfortable. Take risks, and do not let the fear of making mistakes prevent you from doing anything at all.
So, hop to it! It is never too early to think about statistical leadership.