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Job Description
Biostatistician responsible for reviewing and advising on statistical aspects of drug development, interacting with medical colleagues and company representatives.
The ideal candidate will have a postgraduate qualification in statistics, biostatistics, or related quantitative discipline, and a sound understanding of basic statistical and clinical trial methodology.
The Biostatistician will work closely with the Technical Specialist Team Lead and other managers to ensure effective co-ordination and co-operation across all areas of assessment.
Responsibilities:
- Support the Technical Specialist Team Lead in the ongoing development of the Clinical Assessment section.
- Prepare work objectives for the section and prioritise tasks to ensure operational goals are achieved.
- Analyse and critically appraise statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications.
- Prepare assessment reports and attend meetings with other Irish Agencies as required.
- Collaborate with medical colleagues and company representatives to ensure effective co-ordination and co-operation across all areas of assessment.
- Conduct statistical analyses and prepare reports as required.
- Stay up-to-date with regulatory requirements and industry developments.
Requirements:
- Postgraduate qualification (MSc/PhD) in statistics, biostatistics, or related quantitative discipline.
- Sound understanding of basic statistical and clinical trial methodology relevant to the regulation of medicines.
- Knowledge and understanding of the drug development process (pre-clinical, quality, clinical, and post-approval).
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
Salary: €73-84K
All candidates must have a valid EU work permit and be currently residing in Ireland.