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 sinead.cullen@lifescience.ie
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