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Senior Statistician Oxford United Kingdom,  


Posted on : 17 January 2017

Project Description

We are looking for professional, qualified and enthusiastic candidate to take up a full-time, permanent position as a Senior Statistician role to support our Global Clinical Research teams. Full time / Oxford Office based Responsibilities: Leading all biostatistics activities related to clinical trials as responsible project statistician Communication line for project teams, clients and vendors on statistical questions Development and review of statistical sections of protocols, including sample size calculations Development of statistical analysis plans Development and documentation of analysis database structures (i.e. SAS analysis data set structures) Development of SAS program requirements and specifications SAS programming and program validation Review and QC of statistical deliverables (tables, listings, figures, etc.) Performing statistical analysis and reporting results Providing consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics Participation in bid defense meetings and kick-off meetings Preparation and delivery of presentations at investigators’ meetings Coaching and training of statisticians and SAS programmers Preparation for and attendance at internal and third-party study audits pertinent to Statistics Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department Qualifications: MSc in Statistics or equivalent Relevant industry experience in clinical research, including significant experience in biostatistics and SAS programming Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research Very Good knowledge and understanding of the SAS programming language Strong 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 Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies Strong ability to represent biostatistics in bid defenses Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) Skills: Excellent presentation and communication skills Advanced knowledge of SAS software Good knowledge of MS office software Advanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus To apply please send your CV and covering letter to job@psi-cro.com

Locations

UK OXFORD

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