Collects and assesses adverse-event information for marketed and investigational products, manages global safety-database data, supports regulatory compliance and inspections, and answers case-report queries.
About this role
This Statistician supports clinical trials and post-marketing surveillance (PMS) within a drug-development organization. Working with clinical teams, clinicians, clinical pharmacologists, data managers, clinical programmers, regulatory stakeholders, and global Therapeutic Area statisticians, the role provides statistical expertise for development and submission activities.
Responsibilities cover study design, statistical analysis plans, interpretation of results, and outputs such as topline and clinical study reports. The role supports publications, scientific presentations, regulatory-query responses, development planning, and compliant delivery of study, PMS, and submission-level statistical work. It also contributes to research on statistical methodology for clinical trials and PMS.
Applicants need an advanced degree in statistics, biostatistics, or a related field, strong statistical or epidemiological skills applied to clinical trials or PMS, broad drug-development knowledge, and knowledge of clinical medicine and regulatory requirements. Effective written and verbal communication and cross-functional statistical leadership are also required.
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