Job Title: Statistical Consultant
We are seeking an experienced statistical consultant to contribute their expertise in statistical analysis and review of drug development applications.
Responsibilities:
* Analyse and critically appraise statistical aspects of pre-marketing applications, including dossiers for medicines, scientific advice applications, and clinical trial applications.
* Liaise with assessment teams in the assessment of these applications.
* Inform and influence National and European advisory and decision-making committees.
* Provide statistical advice to stakeholders to ensure accurate and unbiased presentation of study/project results and conclusions.
* Contribute to peer review of national and EU scientific evaluation documents.
* Represent the organization at relevant National and EU meetings, when required.
* Maintain and enhance personal and technical competence by staying up-to-date with new statistical methodology and other development activities.
* Contribute to and assist in the delivery of statistical training to staff.
* Provide data analysis to support policy direction and other functions as determined by the organization.
* Assist in ensuring the accuracy of relevant data inputted in computer databases and information systems.
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 (e.g. EMA and FDA).
* Sound understanding of statistical and clinical trial methodology, including up-to-date techniques available for regulating medicines across the breadth of the drug development process.
* Significant work experience in designing, analyzing, and interpreting randomised, controlled clinical trials across all stages of clinical development and in various therapeutic areas.