Biostatistician

Biostatistician, Clinical Assessment

The Biostatistician will use their statistical expertise to review Marketing Authorisation and Clinical Trial Applications and advise on good drug development, interacting with medical colleagues and multi-disciplinary advisory committees and company representatives as required.

The Biostatistician will work closely and maintain effective working relationships, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the department are met.

o Strategic Objectives o Supporting the Technical Specialist Team Lead and other managers in the Clinical Assessment section in the on-going development of the section

o Working with the Technical Specialist Team Lead and other managers in the Clinical

Assessment section in the preparation of work objectives for the section

o Working with the Technical Specialist Team Lead and other managers in the Clinical Assessment section to prioritise work objectives and to ensure that the operational goals of the section are achieved

o Operational Objectives - Working with the Technical Specialist Team Lead and other managers in the Clinical Assessment section to plan and organise work tasks that ensure efficient delivery of work

o Assisting in the compilation of data and preparation of reports as required

o Attending Groups/Committees/meetings at the European Medicines Agency

(EMA), as required

Attending meetings with other Irish Agencies, as required

o Technical Objectives o Analysing and critically appraising statistical aspects of pre-marketing applications including dossiers for medicines, scientific advice applications and clinical trial applications, and preparing assessment reports. The assessment includes but is not limited to statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses and imputation methods for missing data.

REQUIREMENTS:

o A postgraduate qualification (MSc/PhD) in statistics, biostatistics or related quantitative discipline

o Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval)

o Sound understanding of basic statistical and clinical trial methodology relevant to the regulation of medicines

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