Biostatistician Our client, a large regulatory body, is currently recruiting for a Biostatistician to join their team. As a Biostatistician, you will use your statistical expertise to review Marketing Authorisation Applications and advise on good drug development.
Responsibilities Analyze and critically appraise statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications, and the preparation of assessment reports. Liaise with assessment teams in the evaluation of the mentioned applications. Inform and influence National and European advisory and decision-making committees. Provide statistical advice to stakeholders to ensure accurate presentation of study/project results and conclusions. Contribute to the peer review of national and EU scientific evaluation documents. Represent the organization at relevant National and EU meetings. Maintain and enhance personal and technical competence by staying updated on new statistical methodology. Assist in the delivery of statistical training to the organization's staff. Provide data analysis to support policy direction. Assist managers in ensuring data accuracy in computer databases and information systems. Requirements Have a Master's or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology. Knowledge and experience of drug development and understanding drug development as a continuum. Experienced with ICH GCP, regulatory guidelines (e.g., EMA and FDA). Sound understanding of a wide range of statistical and clinical trial methodology relevant to the regulation of medicines. Significant work experience in the design, analysis, and interpretation of randomized, controlled clinical trials. For more information, please contact Sinéad Cullen on +353879500821 or ******
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