ABSTRACT
An appropriately qualified and experienced statistician is a valuable player in any drug development team in the biopharmaceutical industry. This is well acknowledged and even articulated in the ICH E9 guidance [61]. The biostatistician is a team player, who interfaces and consults various multidisciplinary clinical development teams in the day-to-day work. To maximize impact, the biostatistician’s skillset should be broad and diverse, and reflect technical, tactical, strategic, and regulatory requirements of drug development.
