Our client, a national regulator, are seeking a Biostatistician to assist with the review of clinical trial data in the drug dossier applications it receives. This is a new role based in Dublin city centre. A fuller JD is available upon request.
• The analysis and critical appraisal of statistical aspects of pre-marketing application including dossiers for medicines, scientific advice applications and clinical trial applications, and the preparation of assessment reports. The assessment includes but is not limited to statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses and imputation methods for missing data
• Informing and influencing National and European advisory and decision-making committees, including the Commission on Human Medicines (CHM) and the Committee for Medicinal Products for Human Use (CHMP)
• Provide statistical advice on behalf of the organisation to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias
QUALIFICATIONS AND EXPERIENCE
• Have a Master or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology
• Knowledge and experience of drug development (clinical and post-approval) and understanding drug development as a continuum
• Experienced with ICH GCP, regulatory (e.g. EMA and FDA) guidelines
• Sound understanding of a wide range of statistical and clinical trial methodology, including the most up-to-date techniques available that are relevant to the regulation of medicines, as employed across the breadth of the drug development process.
• Significant work experience in the design, analysis and interpretation of randomised, controlled clinical trials across all stages of clinical development and in a wide range of therapeutic areas.
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252