Biostatistics Assessor Role
This role involves providing statistical expertise to the Centralised and Clinical Trials licensing section, focusing on the assessment of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications.
The successful candidate will have a strong background in statistics, with experience employing analytical thinking on complex data and statistics. They will be able to make appropriate and tailored recommendations, comprehensible by multidisciplinary audiences.
Key Responsibilities:
* Analysing and critically appraising statistical aspects of pre-marketing applications
* Preparing assessment reports and contributing to benefit-risk assessments
* Providing expertise on good drug development and interacting with medical colleagues, advisory committees, and company representatives
* Assisting in the compilation of data and preparation of reports as required
* Attending working groups/committees/meetings at the European Medicines Agency (EMA)
Requirements:
* A postgraduate qualification (MSc/PhD) in statistics, medical statistics, or biostatistics
* A relevant 3rd-level honours degree in mathematical, life science, or healthcare disciplines
* Experience employing analytical thinking on complex data and statistics
* Sound understanding of statistical methodology relevant to the regulation of medicines and clinical trials
Benefits:
* Opportunity to work in a dynamic team and contribute to the advancement of regulatory science
* Chance to develop and enhance personal and technical competence by staying up-to-date with new statistical methodologies
About This Job:
This is an exciting opportunity to join our team and contribute to the review of pre-marketing applications for medicinal products. If you are a motivated individual with a passion for biostatistics, we encourage you to apply for this role.