Data Analysis Expert

2 days ago

Dublin, Dublin City, Ireland beBeeStatistical Full time €100,000 - €130,000

Biostatistical Specialist

We are seeking a highly skilled Biostatistical Specialist to join our team.

Job Description

The role of the Biostatistical Specialist will be to use statistical expertise to review applications and advise on good drug development practices.

Responsibilities

  • Analyse and critically appraise statistical aspects of pre-marketing application, including dossiers for medicines, scientific advice applications and clinical trial applications, and prepare assessment reports.
  • Liaise with assessment teams in the assessment of the above mentioned applications.
  • Inform and influence national and European advisory and decision-making committees.
  • Provide statistical advice to stakeholders to ensure that planned study/project results and conclusions are presented accurately and without bias.
  • Contribute to the peer review of national and EU scientific evaluation documents.
  • Represent the organisation at relevant national and EU meetings.
  • Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology.
  • Contribute to and assist in the delivery of statistical training to staff.
  • Provide data analysis to support policy direction.
  • Assist in ensuring the accuracy of relevant data inputted in computer databases and information systems.

Requirements

  • A Masters or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology.
  • Knowledge and experience of drug development and understanding drug development as a continuum.
  • Experienced with ICH GCP, regulatory guidelines.
  • Sound understanding of statistical and clinical trial methodology.
  • 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.

Benefits

This is an exciting opportunity to work in a dynamic environment and contribute to the advancement of drug development.

Others

For more information, please contact us.

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