SENIOR STATISTICIAN

<p><strong>In this role, you will:</strong></p><ul><li>Lead all biostatistics activities related to clinical trials as responsible project statistician</li><li>Communicate with project teams, clients and vendors on statistical questions</li><li>Develop and review statistical sections of protocols, including sample size calculations</li><li>Develop statistical analysis plans</li><li>Develop and document analysis database structures (i.e. SAS analysis data set structures)</li><li>Develop SAS program requirements and specifications</li><li>SAS programming and program validation</li><li>Review and QC of statistical deliverables (tables, listings, figures, etc.)</li><li>Perform statistical analysis and report results</li><li>Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products</li><li>Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics</li><li>Participate in bid defense meetings and kick-off meetings</li><li>Train statisticians and SAS programmers</li><li>Prepare and deliver presentations at investigators' meetings</li><li>Address audits findings/recommendations, and follow-up on and resolution of audit findings</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>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</li><li>Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies</li><li>Expert knowledge and understanding of the SAS programming</li><li>Expert knowledge and understanding of CDISC ADaM standard</li><li>Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)</li><li>Ability to work in English&#xa0;</li></ul><p><strong><u>Please submit your CV in English.</u></strong></p> <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.</p>