Job Description
You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead. In this role, you will: Act as a communication line for project teams, clients, vendors and internal team on statistical questions Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents Review statistical deliverables such as tables, figures, listings and analysis datasets Conduct departmental induction course and project-specific training for statisticians and SAS programmers Prepare for and attend internal and external study audits pertinent to Statistics Participate in preparation of internal/external audits follow up Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics Liaise with DM on statistical questions related to data issues Participate in bid defense and in kick-off meetings Lead teams of SAS programmers and/or statisticians on the project level MSc in Statistics or equivalent Full working proficiency in English Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research Expert knowledge and understanding of the SAS programming Expert knowledge and understanding of CDISC ADaM standard Expert knowledge and understanding of pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis Expert knowledge and understanding of Phoenix WinNonlin and NLME Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) Ability to apply a range of advanced stat
