- Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III)
- Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs)
- Design and review statistical methodologies for efficacy and safety analyses
- Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards
- Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs
- Collaborate with clinical development, data management, programming, regulatory, and medical teams
- Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA)
- Provide strategic input on study design, endpoint selection, and sample size calculations
- Mentor junior statisticians and provide technical guidance
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