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Senior Statistician - Home BasedRef: BBBH23074

Salary:£45000 - £58000 per annum

Added:12 Jun 2018

Region: South East

Sector: Pharmaceutical

Sub Sector: Statistics

Primary responsibilities: *Leading biostatistics activities related to clinical trials *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 Communication: *Communication line for project teams, including statisticians and SAS Programmers *Communication line for customer on statistical questions *Communication line for vendors on statistical questions Training: *Conduct of project-specific training of statisticians and SAS programmers *Coaching and training of statisticians (non-project-related) *Preparation and delivery of presentations at investigators' meetings Quality Assurance: *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 Experience: *MSc in Statistics or equivalent *At least 5 years of industry experience in clinical research *At least 5 years of industry experience in biostatistics *At least 5 years of experience in 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

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