[Immediate Start] Biostatistician

1 week ago


Dublin, Ireland Life Science Recruitment Full time

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 Authorisation 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 the preparation of assessment reports.

- Liaise with assessment teams in the evaluation of the mentioned applications.

- Inform and influence National and European advisory and decision-making committees.

- Provide statistical advice to stakeholders to ensure accurate presentation of study/project results and conclusions.

- Contribute to the peer review of national and EU scientific evaluation documents.

- Represent the organization at relevant National and EU meetings.

- Maintain and enhance personal and technical competence by staying updated on new statistical methodology.

- Assist in the delivery of statistical training to the organization's staff.

- Provide data analysis to support policy direction.

- Assist managers in ensuring data accuracy in computer databases and information systems.

Requirements

- Have a Master's 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 (e.g., EMA and FDA).

- Sound understanding of a wide range of statistical and clinical trial methodology relevant to the regulation of medicines.

- Significant work experience in the design, analysis, and interpretation of randomized, controlled clinical trials.

For more information, please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie

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