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Details

Biostatistician


Reference:SCABEA-455845 Location: Dublin City Centre
Qualification:MastersExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Biostatistician

Biostatistician
Our client, a national regulator, are seeking a Biostatistician to join their team. This is a new role based in Dublin city centre. As the Biostatistician you will use yourstatistical expertise to review Marketing Authorisation Applications and advise on good drug development. Interviews for this role will be held via Skpye at the start/mid July.


KEY RESPONSIBILITIES

  • Analyse and critically appraise 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
  • Inform and influence 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
  • Contribute to the peer review of national and EU scientific evaluation documents
  • 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
  • Represent the organisation at relevant National and EU meetings, when required
  • Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data and other personal development activities
  • Contribute to and assist in the delivery of statistical training to the organisations staff
  • Provide data analysis to support policy direction, and other functions as may be determined depending on the needs of the organisation
  • Assist the Clinical Assessment Manager and other managers in the Clinical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the organisation

QUALIFICATIONS AND EXPERIENCE

  • 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.

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252