Statistical Expert
Our team is seeking a skilled Biostatistician to contribute to the analysis and review of applications for medicines. As a Statistical Expert, you will utilize your statistical expertise to advise on drug development and analyze clinical trial data.
Responsibilities:
* Analyze and appraise statistical aspects of pre-marketing applications, including dossiers for medicines and clinical trial applications.
* Collaborate with assessment teams to review applications and prepare assessment reports.
* Provide statistical advice to stakeholders, ensuring accurate presentation of study results and conclusions.
* Contribute to peer review of scientific evaluation documents and represent the organization at relevant meetings.
* Maintain and enhance personal and technical competence by staying up-to-date with new statistical methodology and participating in professional development activities.
Requirements:
* Hold a Master's or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology.
* Have knowledge and experience of drug development, including clinical and post-approval processes.
* Be familiar with ICH GCP and regulatory guidelines, such as those from the EMA and FDA.
* Possess a sound understanding of statistical and clinical trial methodology, including up-to-date techniques.
* Have significant work experience in designing, analyzing, and interpreting randomized controlled clinical trials across various stages of clinical development and therapeutic areas.