Related skills
r sas cdisc sdtm oncology📋 Description
- Provide statistical leadership for oncology trials across Phase I–III.
- Lead SAPs, study protocols, and CSRs with accuracy.
- Oversee SDTM/ADaM datasets and TLFs per CDISC standards.
- Support interim analyses and DMC activities; adaptive designs.
- Contribute to regulatory submissions (IND, NDA, BLA) and health authority responses.
- Mentor junior statisticians and collaborate with cross-functional teams.
🎯 Requirements
- PhD or MS in Statistics, Biostatistics, or related field.
- 8+ years (MS) or 6+ years (PhD) biostatistics experience.
- Strong oncology clinical trials experience.
- Proficiency in SAS and/or R.
- CDISC SDTM/ADaM knowledge; CSRs, SAPs, protocols.
- Experience with regulatory submissions and health authority interactions.
🎁 Benefits
- Global CRO with 28+ years in oncology development.
- Strong focus on quality, development, and supportive culture.
- Career development and training opportunities.
- Equal opportunity employer with diverse teams.
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