Job Summary
A company is looking for an Executive Director, Biostatistics and Data Management.
Key Responsibilities
- Lead the biostatistics strategy for clinical development projects
- Provide statistical leadership for clinical development plans, regulatory submissions, and product support initiatives
- Oversee CRO and statistical vendors to ensure quality deliverables and collaborate cross-functionally on statistical analyses
Required Qualifications
- 15+ years of experience in pharmaceutical/biotech clinical drug development, with 10+ years in oncology
- Proficiency in statistical programming languages/software such as SAS, R
- Extensive knowledge of FDA/ICH guidelines, CDISC standards, and the global drug development process
- Ph.D. in Statistics, Biostatistics, Mathematics, or a related field
- Must be legally authorized to work in the US without employer sponsorship
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