Senior Statistical Expert

2 weeks ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €75,000 - €104,250

Biostatistician Role

Job Description

We are seeking a highly skilled Biostatistician to join our team. As a Biostatistician, you will utilise your statistical expertise to review Marketing Authorisation Applications and provide advice on drug development.

The role involves using statistical methods to critically appraise applications for medicines, scientific advice, and clinical trials, and preparing assessment reports. This includes evaluating statistical methods, design, analysis plans, sample size, sensitivity analyses, and imputation methods for missing data.

You will also liaise with assessment teams, inform and influence advisory committees, and provide statistical advice to stakeholders.

Additionally, you will contribute to the peer review of national and EU scientific evaluation documents and maintain and enhance personal and technical competence by staying up-to-date with new statistical methodology.

Required Skills and Qualifications
  • Masters or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology
  • Knowledge and experience of drug development (clinical and post-approval) and understanding drug development as a continuum
  • Experienced with ICH GCP, regulatory guidelines, and sound understanding of statistical and clinical trial methodology
  • Significant work experience in designing, analysing, and interpreting randomised, controlled clinical trials across all stages of clinical development and in a wide range of therapeutic areas
Benefits

This role offers the opportunity to work with a reputable organisation and contribute to the development of life-changing medicines.

Others

The ideal candidate will be able to demonstrate excellent communication skills, both written and verbal, and the ability to work independently and as part of a team.

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