.Overview: TFS HealthScience is excited to be expanding our Biostatistic team and we are looking for an experienced, highly motivated Senior Biostatistician who shares our vision of providing clinical research excellence. Our Biostatistic team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver. Our core values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.TFS HealthScience is looking for a Senior Biostatistician, home based in Europe. The Senior Biostatistician is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Statistical tasks in assigned Study Teams, according to company policies, SOPs and regulatory requirements. The Senior Biostatistician should take the full statistical responsibility for all essential job functions and support other Biostatisticians in their role.What can we offer you? A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.Responsibilities:As a member of the Study Team, responsible for the planning, performance, report and documentation of statistical tasks during the study process.Assist in the development of Study Protocols, CRFs and reports/manuscripts by providing statistical input.Write the statistical sections in the Study Protocol.Review the Study Protocol.Review the CRF to ensure that the design and structure of the CRF meets the specific statistical requirements defined in the study protocol.Assist in performing/Review sample size calculations.Define randomisation procedures and producing randomisation lists.Define appropriate methods for statistical analysis.Write the Statistical Analysis Plan.Design the Data Presentation Plan.Plan and perform statistical analysis (interim and/or final) in accordance with the Study Protocol and the statistical analysis plan.Validation of the defined statistical methods (by e.G. goodness-of-fit tests or model checking).Perform programming of statistical analyses and study output.Document and validate programmes and files for analysis
