ROLE OF A BIOSTATISTICIAN IN DRUG DEVELOPMENT PROGRAMS Impact beyond clinical studies By Natasa Rajicic
Statisticians contribute to clinical study design, conduct, analysis and reporting - where their involvement has been well established. They are typically part of a larger biometrics team where they work closely with clinicians, data managers and programmers, and contribute to the study design, protocol writing, dataset formats and monitoring plans. For example, one of the main deliverables for a statistician working on a clinical study is the completion of a Statistical Analysis Plan (SAP) where they detail the statistical considerations. These include the planned sample size, statistical approaches for the evaluation of endpoints and testing the stated hypothesis, definitions of the analysis populations and estimands, and the treatment of missing observations, to name just a few.
However, the input from a statistician with broad experience in different quantitative strategies goes beyond sample size considerations, creation of the SAP document, and summaries of the results. When they are given the room to work closely with clinical pharmacologists, data scientists and other types of quantitative strategists, statisticians can take a broad view of the clinical development plan to synthesise existing information and consider the range of pathway options. They can help detect any knowledge gaps, identify the right data needed for present and future
needs, and help manage the risks along the way. The best statisticians are knowledgeable both about a product and its clinical development pathway, and about a whole range of quantitative approaches and strategies that can be employed to better inform decisions made along the development path. Their contribution can add to data-driven decision-making at every stage of the development. Their evaluation of the existing data can feed into the design of the trial through historical controls, help identify a high-value sub-population, or evaluate the collection of patient-centric measurements. They 4
