Assessor, Methodology (Biostatistics) - Centralised and Clinical Trials Licensing - Human Products Authorisation and Registration
This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.
The Vacancy
The Human Products Authorisation and Registration (HPAR) Department provides human medicines licensing services to the Health Products Regulatory Authority (HPRA). HPAR is structured with two main technical sections – one delivering assessments for products authorised through mutual recognition, decentralised and national mechanisms, and the other delivering assessments for products authorised through the centralised (EU) mechanism, and for clinical trials.
The position of Assessor, Methodology (Biostatistics) will be based in the Methodology team in the Centralised and Clinical Trials licensing section and will report to the Executive Assessor (Methodology). The Methodology team delivers assessments for products authorised through the centralised (EU) mechanism, and clinical trials. The Methodology team consists of clinical pharmacology assessors and biostatisticians/statistical assessors.
The Assessor, Methodology (Biostatistics) will use their statistical and professional expertise to lead the assessment and review of the statistical aspects of marketing authorisation applications and clinical trial applications. The Assessor, Methodology (Biostatistics) will critically analyse complex clinical and scientific information, make sound judgements on the value of the statistical methodologies employed, discuss considerations with statistical and non-statistical colleagues and write informative assessment reports for a multi-disciplinary readership, contributing to benefit risk assessment. The assessment may involve data analysis and interpretation, and dissemination of such to a multi-disciplinary audience.
The Assessor will provide expertise on statistical components of good drug development, interacting with colleagues, multi-disciplinary advisory committees and company representatives, as required. The Assessor will contribute to providing in-house statistical expertise to other technical sections in HPAR, as required.
The Assessor will work closely and maintain effective working relationships with colleagues in the Methodology team, the section and the HPAR department, to ensure effective co-ordination across all areas of assessment and to ensure the objectives of the HPAR department are met. The Assessor will maintain effective working relationships with colleagues in other sections and departments of the HPRA, to ensure effective conduct on issues requiring cross-functional input.
The Assessor will have the opportunity to participate in the European Medicine Agency’s (EMA) Methodology European Specialised Expert Community, where the Assessor will knowledge share and interact with colleagues in the topic area of biostatistics and other key areas of methodology. As regulatory methodology is a rapidly evolving field, the Assessor is expected to adapt to emerging developments, and support colleagues through ongoing knowledge sharing and dynamic upskilling.
The Company
We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.
Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.
The Benefits
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