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Director, Biostatistics (Oncology Indication Lead)
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- Job Title: Director, Biostatistics (Oncology Indication Lead) Full time permanent - Direct with a global pharmaceutical company Location: Basking Ridge, NJ - this can be fully remote but need to be onsite once every 3 months, and or very important meetings Must be US Based in EST or CST time zones Prior experience as a Statistician indication lead for an Oncology trial is needed.
- This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
- 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).
- Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
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