Role Overview:
Statistical Expertise
We are seeking a highly skilled Biostatistician to join our team in a regulatory body. This individual will utilize their statistical expertise to review Marketing Authorisation Applications and advise on good drug development.
The ideal candidate will have a strong background in biostatistics, including experience in clinical trials methodology, with knowledge of ICH GCP, regulatory guidelines, and sound understanding of a wide range of statistical and clinical trial methodology.
In this role, the Biostatistician will be responsible for analysing and critically appraising statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications. They will also prepare assessment reports that include statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses, and imputation methods for missing data.
Liaison with assessment teams and informing and influencing National and European advisory and decision-making committees, including the Commission on Human Medicines (CHM) and the Committee for Medicinal Products for Human Use (CHMP), is also a key aspect of this role.
Additionally, the successful candidate will provide statistical advice on behalf of the organisation to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias. Representation at relevant National and EU meetings, when required, and maintaining and enhancing personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data, and other personal development activities, will also be essential.
Key Responsibilities:
* Analyse and critically appraise statistical aspects of pre-marketing applications.
* Prepare assessment reports that include statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses, and imputation methods for missing data.
* Provide statistical advice to stakeholders.
* Represent the organisation at relevant National and EU meetings.
Requirements:
* 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 a wide range of statistical and clinical trial methodology.
Desirable Qualities:
* Significant work experience in the design, analysis, and interpretation of randomised, controlled clinical trials across all stages of clinical development and in a wide range of therapeutic areas.