Biostatistiker med erfaring inden for kliniske studier til Lægemiddelstyrelsen

This mid-level biostatistician role requires expertise in statistical methodologies specifically applied to clinical studies within the pharmaceutical regulatory environment. The ideal candidate should have a strong foundation in biostatistics, including experience designing, analyzing, and interpreting data from clinical trials. Familiarity with regulatory requirements and guidelines relevant to drug development and approval processes is essential, as the position supports the Danish Medicines Agency (Lægemiddelstyrelsen). Key competencies include proficiency in statistical software commonly used in clinical research, such as SAS, R, or similar tools, to manage and analyze complex datasets. The candidate should demonstrate the ability to collaborate effectively with multidisciplinary teams, including clinical researchers, regulatory professionals, and medical experts, to ensure the statistical integrity and compliance of clinical study data. Experience with survival analysis, longitudinal data analysis, and other advanced statistical techniques relevant to clinical trials is advantageous. Strong communication skills are important to clearly present statistical findings and contribute to regulatory documentation and decision-making. Overall, this role demands a combination of solid biostatistical knowledge, practical experience in clinical trial settings, and an understanding of the regulatory framework governing medicinal products.