The Senior Quantitative Safety Scientist 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.
1. Provides strategic leadership regarding quantitative safety science during the whole life cycle of a drug, comprising all relevant technical and disease area knowledge 2. Drives and steers the strategic quantitative safety framework for clinical programs in close collaboration with project teams, especially the Safety Management Team 3. Represents quantitative safety in the Safety Management Team 4. In collaboration with clinical counterparts (Brand Safety Leaders, Global Brand / Project Medical Directors) and other quantitative counterparts (Statistical Scientist, Epidemiologist, CSU statistician) influences and negotiates the development Safety Profiling Plan (SPP). 5. 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 documents (e.g. DMCs, DSUR), submission documents (SCS, CO, CDS, RMP) and post-marketing documents (e.g. PSUR, CDS updates, RMP updates) in a consistent, efficient and harmonized manner across all data sources 6. Coordinates quantitative safety activities to answer requests from health authorities and to prepare for safety advisory committee boards (e.g. AdCom). Interacts with Health Authorities and external consultants as appropriate. Supports and defends analyses and their interpretations at Health Authority Meetings. 7. Represents quantitative safety at drug project meetings with respect to statistical scientific input and at internal/external meetings with respect to communication and training of quantitative safety methods. 8. Provides general consultancy support to clinical teams and brand safety leaders regarding quantitative safety 9. Provides biostatistics and drug development expertise to infrastructure and process improvement initiatives; may lead such initiatives 10. Provides technical statistical expertise and leadership and serves as a role model for innovation of quantitative safety sciences 11. Maintain scientific competence by following up new methods, continuing education in the field of expertise and collaboration with external consultants. 12. Actively participate in scientific meetings by giving presentations.
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University degree in statistics or mathematics or related area (PhD preferred) English 1. 6 to 8+ years of experience in positions with increasing relevant responsibilities in the Pharmaceutical Industry. 2. 4+ years expert knowledge and substantial experience of statistical safety methods applied to drug development and post-marketing safety assessment. 3. Contributes to external white-papers/policy shaping best practice statistical science. Has strong and established record of developing/establishing quantitative safety statistical excellence. Established experience in leading global scientific improvement/ change initiatives. 4. Strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence 5. Expert scientific leadership skills demonstrated in facilitating and optimizing the quantitative safety strategy. Strong track record for global scientific leadership in the development and evaluation of modern quantitative
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