Senior Statistician

In this role, you will: - Lead all biostatistics activities related to clinical trials as responsible project statistician - Communicate with project teams, clients and vendors on statistical questions - Develop and review statistical sections of protocols, including sample size calculations - Develop statistical analysis plans - Develop and document analysis database structures (i.e. SAS analysis data set structures) - Develop SAS program requirements and specifications - SAS programming and program validation - Review and QC of statistical deliverables (tables, listings, figures, etc.) - Perform statistical analysis and report results - Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products - Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics - Participate in bid defense meetings and kick-off meetings - Train statisticians and SAS programmers - Prepare and deliver presentations at investigators' meetings - Address audits findings/recommendations, and follow-up on and resolution of audit findings - MSc in Statistics or equivalent - Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research - Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information - Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies - Expert knowledge and understanding of the SAS programming - Expert knowledge and understanding of CDISC ADaM standard - Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) - Ability to work in English