What Defines a Good Clinical Statistician?

I recently attended a leadership training session where a colleague shared an experience involving a physician on a Data Monitoring Committee (DMC) who questioned the qualifications of the committee statistician. The physician was concerned because the statistician often remained quiet during routine DMC meetings, which typically focus on safety issues. My colleague, however, was confident that the statistician was fully qualified for the role.

This raises an interesting question: Is it normal for a good statistician to be quiet when discussions fall outside their area of expertise? More broadly, what truly defines a good clinical statistician in drug development?

In my view, the core competencies of a good clinical statistician include:

• Statistical skills

• Drug development experience (clinical, regulatory, and operational)

• Relevant therapeutic area experience

Among these, statistical skills are unquestionably the most critical - just as medical knowledge is the most fundamental for a physician. No one would question whether airmanship is the most essential qualification for a pilot, right?

Drug development experience is also vital, as it is intrinsic to what it means to be a “clinical” statistician. In this sense, a good clinical statistician is more than simply a statistician with good statistical skills.

Therapeutic area experience, while certainly valuable, is generally less critical. A capable clinical statistician can usually acquire necessary therapeutic area knowledge more readily than deep statistical or drug development expertise. Working knowledge of disease mechanisms and drug biology is generally sufficient to support sound statistical practice in clinical trial design, conduct, and analysis.

The physician on the DMC likely had unrealistic expectations of the committee statistician. Most clinical statisticians do not - and are not expected to - possess specialized medical expertise. A clinical or DMC statistician’s primary responsibility is to ensure that clinical trial data are analyzed, interpreted, and communicated appropriately, rather than to weigh in on medical issues beyond their expertise. Likewise, a good physician is not expected to be an expert in statistics.

Other competencies, such as leadership, communication, and interpersonal skills, are undoubtedly very important, but they are not unique or "core" to clinical statisticians. These soft skills are broadly valuable across nearly all professions and can elevate a good clinical statistician to a truly exceptional one.