Related skills
statistics biostatistics ich cdisc hematology๐ Description
- Lead statistics for hematology studies across development phases.
- Partner with clinical, regulatory, programming, and data mgmt teams.
- Deliver high-quality statistics for study execution and submissions.
- Contribute to protocol design, endpoints, estimands, analysis methods.
- Oversee generation and validation of TLFs and other outputs.
- Mentor statisticians and programmers.
๐ฏ Requirements
- MS or PhD in Statistics or Biostatistics.
- Significant hematology (oncology/hem-onc) experience.
- Prior regulatory submission experience.
- Ability to work independently in fast-paced matrixed environment.
- Strong communication and stakeholder management.
- Proven track record supporting regulatory submissions.
- CDISC, ICH, and global regulatory requirements knowledge.
๐ Benefits
- Remote-friendly, global CRO culture.
- Opportunities for career growth.
- Collaborative, cross-functional teams.
- Competitive benefits and ongoing training.
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