Job Summary
A company is looking for a Principal Biostatistician.
Key Responsibilities
- Provide statistical support for all phases of clinical development, including writing and reviewing protocols and statistical analysis plans
- Conduct statistical analyses, generate datasets, and present results to project teams and sponsors
- Lead statistical activities for studies, ensuring compliance with budgets and timelines
Required Qualifications
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years of experience; or PhD with 7+ years of experience
- Experience with SAS programming
- Knowledge of ICH guidelines, CDISC data structures, and FDA regulations
- Broad knowledge of advanced statistical concepts and techniques
- Experience in Oncology and rare diseases is preferred
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