[Immediate Start] Biostatistician
1 week ago
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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