SENIOR STATISTICIAN

<p>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.</p><p><strong>In this role, you will:</strong></p><ul><li>Act as a communication line for project teams, clients, vendors and internal team on statistical questions</li><li>Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis</li><li>Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents</li><li>Review statistical deliverables such as tables, figures, listings and analysis datasets</li><li>Conduct departmental induction course and project-specific training for statisticians and SAS programmers</li><li>Prepare for and attend internal and external study audits pertinent to Statistics</li><li>Participate in preparation of internal/external audits follow up</li><li>Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics department</li><li>Liaise with DM on statistical questions related to data issues</li><li>Participate in bid defense and in kick-off meetings</li><li>Lead teams of SAS programmers and/or statisticians on the project level</li></ul> <ul><li>MSc in Statistics or equivalent</li><li>Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research</li><li>Expert knowledge and understanding of the SAS programming</li><li>Expert knowledge and understanding of CDISC ADaM standard</li><li>Expert knowledge and understanding of adaptive designs</li><li>Expert knowledge and understanding of sample size calculation</li><li>Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)</li><li>Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information</li><li>Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies</li><li>Strong presentation and communication skills</li></ul> <p>Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors.&#xa0;Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.&#xa0;</p>