Biostatistician
We are seeking an experienced Biostatistician to join our regulatory body in Dublin, Ireland. As a key member of the team, you will utilize your statistical expertise to review Marketing Authorisation Applications and provide strategic advice on good drug development practices.
Key Responsibilities
* Conduct thorough analysis and critical appraisal of statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications, as well as prepare assessment reports.
* Liaise with assessment teams to evaluate the aforementioned applications.
* Inform and influence national and European advisory committees, including the Commission on Human Medicines (CHM) and the Committee for Medicinal Products for Human Use (CHMP).
* Provide statistical guidance to stakeholders, such as investigators, sponsors, and others, to ensure that any planned study/project results and conclusions are presented accurately and without bias.
* Contribute to peer reviews of national and EU scientific evaluation documents.
* Represent the organisation at relevant national and EU meetings when required.
* Maintain and enhance personal and technical competence by staying up-to-date with new statistical methodologies and participating in occasional data analysis and other professional development activities.
* Assist in delivering statistical training to the organisation's staff.
* Support policy direction and other functions by providing data analysis as needed.
Required Skills and Qualifications
* Hold a Master's or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology.
* Have knowledge and experience of drug development (clinical and post-approval) and understand drug development as a continuum.
* Be familiar with ICH GCP, regulatory guidelines (e.g., EMA and FDA), and sound understanding of a wide range of statistical and clinical trial methodology.
* Possess significant work experience in designing, analyzing, and interpreting randomised, controlled clinical trials across all stages of clinical development and various therapeutic areas.