The biopharmaceutical industry is challenged by regulatory and other competitive pressures and is in a quest for better and cheaper medicines that reach patients with unmet medical needs with reduced risks. The changing dynamics have presented new opportunities for those, for instance, biostatisticians who can help business and regulatory leaders make quick and accurate decisions about drug development and market authorisation. The role of a biostatistician in clinical research is not just a necessity — it is a competitive advantage. Biostatisticians play a key role in helping biopharma companies through helping reduce risks, decrease costs, accelerate timelines, ensure speedier results and improve the quality of regulatory submissions. There are also significant challenges regarding pricing and profiling of compounds.
Phases of clinical researchClinical research is typically done in four phases through all of which biostatisticians are involved — from the design of the clinical trial to identifying what data should be collected, gathering it, interpreting and analysing it and report generation with appropriate statistical and scientific interpretations. They also deal with challenges such as missing data, interim looks, multiple hypotheses and multiple endpoints.
Historically, biostatisticians were viewed as professionals who would crunch data and generate statistical analyses which would be interpreted by others. Today, however, they are recognised as interpreters and consolidators of mountains of data . They are involved in identifying important sources of variability and uncertainty and subsequently designing and analysing the same data to eliminate the uncertainty and variability, and designing corresponding studies that ensure better data accuracy. They help ensure that potentially ineffective or unsafe compounds are weeded out as quickly as possible, at the same time ensuring that the process’ ability to produce the most effective compounds with excellent risk benefit profiles, using statistical methods, is not compromised.
Two pathsThere are primarily two career paths for biostatisticians in drug development — a statistician and a statistical programmer. They are not essentially exclusive paths. A typical statistical programmer is different from a software programmer as performing statistical analyses of data requires insight and understanding of data from clinical trials. They not only work with statistics, but also need to have a sound knowledge of the therapeutic area and do programming and analysis in quick turnaround time.
Biostatistics is a highly specialised area that requires technical and domain expertise. Career prospects are attractive as they are a highly skilled and valued resource. To pursue a career in biostatistics (which includes both statistics and statistical programming), one needs a formal postgraduate degree in statistics and/or a SAS programming certification. A degree in life science is a great starting point, followed by training in statistical analysis which can be obtained on the job. Companies have invested in setting up in-house internship programmes. Quintiles has one at its Bengaluru office.
The writer is the senior Director, Biostatistics, Quintiles.
