13 ago - Roma
Experteer Italy
In this role you provide strategic statistical leadership for oncology clinical development programs, with emphasis on hematologic malignancies. You collaborate with cross-functional teams to deliver high-quality statistical outputs that meet regulatory standards. You guide study design, methodology, and interpretation of results, communicating complex analyses to diverse stakeholders. You drive timely, compliant deliverables and quality across the development lifecycle. This opportunity combines leadership, impact on patient outcomes, and the chance to influence oncology programs at a global services leader.
- autonomy and balance
- flexible hours
- Provide principal-level biostatistics leadership for oncology development programs and studies
- Serve as the primary statistical representative on assigned trials and contribute to statistical activities across studies
- Review and QC SDTM datasets and deliverables to ensure CDISC compliance
- Collaborate with Statistical Programming, Data Management, Clinical Operations, and Regulatory teams to ensure timely, accurate outputs
- Assist in interpretation and communication of study results to cross-functional stakeholders
- Ensure statistical deliverables meet quality, regulatory, and timeline expectations
- Summarize and communicate statistical concepts and recommendations to technical and non-technical audiences
- Contribute to study design discussions, protocol development, and methodological considerations as needed
- Advanced experience as a Principal Biostatistician in pharma, biotech, or CRO
- Strong oncology experience, with hematological malignancies experience (e.g., multiple myeloma, leukemia, lymphoma)
- Expertise in CDISC standards, especially SDTM, including QC oversight of SDTM datasets
- Proven ability to work in cross-functional teams and influence stakeholders
- Excellent verbal and written communication skills
- Solid understanding of statistical principles and clinical trial methodology
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