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Director, Biostatistics (Oncology Indication Lead)
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- Prior experience as a Statistician indication lead for an Oncology trial is required.
- This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
- Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project.
- Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted.
- Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).
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