Statistical Consultant

5 days ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €60,000 - €80,000

Job Title: Statistical Consultant

We are seeking an experienced statistical consultant to contribute their expertise in statistical analysis and review of drug development applications.

Responsibilities:
  • Analyse and critically appraise statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications.
  • Liaise with assessment teams in the assessment of these applications.
  • Inform and influence National and European advisory and decision-making committees.
  • Provide statistical advice to stakeholders to ensure accurate and unbiased presentation of study/project results and conclusions.
  • Contribute to peer review of national and EU scientific evaluation documents.
  • Represent the organization at relevant National and EU meetings, when required.
  • Maintain and enhance personal and technical competence by staying up-to-date with new statistical methodology and other development activities.
  • Contribute to and assist in the delivery of statistical training to staff.
  • Provide data analysis to support policy direction and other functions as determined by the organization.
  • Assist in ensuring the accuracy of relevant data inputted in computer databases and information systems.
Requirements:
  • 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 guidelines (e.g. EMA and FDA).
  • Sound understanding of statistical and clinical trial methodology, including up-to-date techniques available for regulating medicines across the breadth of the drug development process.
  • Significant work experience in designing, analyzing, and interpreting randomised, controlled clinical trials across all stages of clinical development and in various therapeutic areas.

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