| || The Quantitative Safety Scientist (Associate Director) is the global lead for the quantitative safety strategy of a drug during the whole life cycle. They are responsible for the discussion and implementation of modern and innovative quantitative methods to robustly evaluate the safety and ultimately the benefit-risk profile of a drug based on data from clinical trials, observational data, spontaneous reports and epidemiological studies. They set the strategic direction for addressing statistical issues for the safety part of drug development, regulatory submissions and health authority requests pre- and post-submission.
Major Accountabilities include:
- Provides strategic leadership regarding quantitative safety science during the whole life cycle of a drug, comprising all relevant technical and disease area knowledge;
- Represents quantitative safety in the Safety Management Team; In collaboration with clinical counterparts and other quantitative counterparts influences and negotiates the development Safety Profiling Plan (SPP);
- Drives statistical strategic and quantitative contributions to data collection, evaluation and presentation of clinical trial safety data, observational safety data and epidemiological safety data during development and post-marketing for a holistic safety assessment in development, submission and post- marketing documents in a consistent, efficient and harmonized manner across all data sources