Biostatistician

2 weeks ago

Dublin, Dublin City, Ireland Scientificjobs Full time

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Biostatistician
Our client, a large regulatory body, is currently recruiting for a Biostatistician to join their team. As a Biostatistician, you will use your statistical expertise to review Marketing Authorization Applications and advise on good drug development.

Responsibilities

  • Analyze and critically appraise statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications, and prepare assessment reports. The assessment includes statistical methods, design, analysis plans, sample size determination, sensitivity analyses, and imputation methods for missing data.
  • Liaise with assessment teams regarding the evaluation of applications.
  • Inform and influence National and European advisory and decision-making committees, such as the CHM and CHMP.
  • Provide statistical advice to stakeholders like investigators and sponsors to ensure accurate and unbiased presentation of study results.
  • Contribute to peer review of national and EU scientific evaluation documents.
  • Represent the organization at relevant National and EU meetings as required.
  • Maintain and enhance personal and technical competencies by staying updated on new statistical methodologies and engaging in personal development activities.
  • Contribute to and assist in delivering statistical training to staff.
  • Provide data analysis to support policy and other organizational functions.
  • Assist the Technical Specialist Team Lead and other managers in ensuring data accuracy in databases and information systems.

Requirements

  • Master's or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology.
  • Knowledge of drug development processes (clinical and post-approval) and understanding of drug development as a continuum.
  • Experience with ICH GCP and regulatory guidelines (EMA, FDA).
  • Strong understanding of statistical and clinical trial methodologies, including current techniques relevant to medicine regulation.
  • Extensive experience in designing, analyzing, and interpreting randomized controlled clinical trials across various therapeutic areas.
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