I am recruiting on behalf of my client, a Regulatory Body, for a Biostatistician. You will use your statistical expertise to review Marketing Authorisation Applications and advice on good drug development, interacting with medical colleagues and multi-disciplinary advisory committees and company representatives as required.
This position is offered on a 2 year contract, as an additional resource to the team.
The salary on offer is the starting point on the salary scale, €61,641. You will avail of flexible hours, a fantastic location in the city centre, and an excellent collaborative working environment.
A full job spec is on offer but a brief summary of the role;
- You will be representing the company at relevant National and EU Meetings
- You will complete 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 Regulatory body to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias
- Have a Masters 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.
- The ability to evaluate complex information from a variety of sources and make effective decisions.
If you are interested in this position, please send your CV to Rebecca O’Connor in Lex Consultancy or call on 016633030. Please note, Interviews are expected to take place mid to late March.