Biostatistician
Our client, a large regulatory body, are currently recruiting for a Biostatistician to join their team. As Biostatistician you will use yourstatistical expertise to review Marketing Authorisation Applications and advise on good drug development.


Responsibilites

• Analyse and critically appraise statistical aspects of pre-marketing application including dossiers for medicines, scientific advice applications and clinical trial applications, and the preparation of assessment reports. The assessment includes but is not limited to statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses and imputation methods for missing data
• Liaise with assessment teams in the assessment of the above mentioned applications
• Inform and influence 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)
• 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
• Contribute to the peer review of national and EU scientific evaluation documents
• 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
• Represent the organisation at relevant National and EU meetings, when required
• Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data and other personal development activities
• Contribute to and assist in the delivery of statistical training to the organisations staff
• Provide data analysis to support policy direction, and other functions as may be determined depending on the needs of the organisation
• Assist the the Technical Specialist Team Leadand other managers in the Clinical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the organisation

• Have a 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 (e.g. EMA and FDA) guidelines
• Sound understanding of a wide range of statistical and clinical trial methodology, including the most up-to-date techniques available that are relevant to the regulation of medicines, as employed across the breadth of the drug development process.
• 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.