Medical statistician

This occupation is found in a wide range of industries including the Pharmaceutical, Health Care, Medical Device Technology, Biotechnology, Food and Environmental Safety, Regulatory and Academic sectors. The name Medical Statistician and biostatistician are synonymous. For simplicity and alignment to terminology used in numerous universities Medical Statistician is used for this apprenticeship. The broad purpose of the occupation is to provide statistical leadership to a multi-disciplinary team, to ensure research studies are designed, conducted, analysed, interpreted and reported in a way which is statistically valid, such that conclusions are trustworthy and reliable. Research studies are conducted in a wide variety of settings, often designed to test potential new treatments for diseases or to investigate new healthcare interventions. Studies collect data, which is then analysed in order to provide evidence based decisions on whether the new treatment/intervention is advantageous to the patient’s condition (e.g. extending life, reducing symptoms or slowing disease onset), whilst ensuring that any unwanted side effects of the treatment are acceptable for the improvement gained. Once enough evidence is gathered, the new treatment/intervention is submitted to a regulatory body for review, with the hope it is approved to be given to patients outside of the research study setting. In their daily work, an employee in this occupation interacts with with regulatory bodies, ethics committee’s senior management, study directors, scientists and doctors, data managers, clinical teams, project managers and medical writers to ensure the work they conduct is statistically valid. The role requires good problem solving skills, applying statistical theory to ensure appropriate conduct, and meaningful, reproducible and appropriately interpreted results. The role of a Medical Statistician is primarily office-based spending their time designing studies, monitoring studies, analysing data, writing reports and contributing to team discussions in meetings. The role may also involve some travel to company sites, conferences, scientific and regulatory meetings, workshops and seminars. In an academic setting a Medical Statistician will also have some interaction with students. An employee in this occupation will be responsible for writing/reviewing statistical sections of protocols (including trial design, randomisation schema, study endpoints and sample size), review and input into study collection materials (electronic Case Report Forms, vendor devices), statistical analysis plans (SAPs) (including specifying the format and structure of planned analysis outputs), contributing to grant applications and creating reports for groups such as data monitoring committees. The occupation also involves programming in a statistical package, such as SAS®, R or other appropriate software, creating summaries and graphical representations and performing analyses of data. They ensure statistical model assumptions based on statistical theory have been met and the analyses applied are appropriate. They provide statistical leadership and oversight of a study to a study team as well as managing their own day-to-day workload to ensure project deliverables are met. They interpret the analyses performed, and contribute to study reports and publications such as manuscripts, posters and slide presentations, to ensure results are appropriately disseminated. A Medical Statistician will also be responsible for keeping abreast of current methodological developments in medical research through reading of journals and attendance at conferences, including publishing their own methodology research and sharing knowledge through statistical tutorials for statistics colleagues and also non-statistical specialists.