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Role Overview:
- Serves as project level biostatistician and provides leadership in statistical strategy for oncology trials.
- Partners with clinical, regulatory, and other teams to develop clinical development plans.
Key Responsibilities:
- Perform statistical analysis and interpret study results for reports and publications.
- Lead development of statistical analysis plans and support regulatory submissions.
- Represent biostatistics in regulatory and cross-functional meetings.
Qualifications:
- PhD or Masters with extensive experience in biostatistics and oncology.
- Expertise in CDISC standards, SAS, R, and experimental design.
- In-depth knowledge of ICH, FDA, and GCP regulations.
Summit Therapeutics Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life. They have multiple global Phase 3 clinical studies and a team of world-class professionals driven by core values of integrity, passion, and collaboration.