As a Principal Biostatistician, you will provide strategic statistical leadership for Oncology clinical trials, with a particular focus on hematological malignancies including multiple myeloma, leukemia, and lymphoma. You will work closely with cross-functional teams to deliver high-quality statistical support across the clinical development lifecycle, ensuring compliance with regulatory and industry standards.
La preghiamo di leggere attentamente la seguente descrizione del lavoro per assicurarsi di essere la persona giusta per questo ruolo prima di candidarsi.
Key Responsibilities
- Provide Principal-level Biostatistics leadership for Oncology clinical development programs and studies
- Lead and contribute to statistical activities across clinical trials, acting as the primary statistical representative on assigned studies
- Review and provide quality control oversight of SDTM datasets and associated deliverables, ensuring compliance with CDISC standards
- Collaborate closely with Statistical Programming, Data Management, Clinical Operations,
and Regulatory teams to ensure accurate and timely delivery of statistical outputs
- Support the interpretation and communication of study results to cross-functional stakeholders
- Ensure all statistical deliverables meet quality, regulatory, and timeline expectations
- Effectively communicate statistical concepts, analyses, and recommendations to both technical and non-technical audiences
- Contribute to study design discussions, protocol development, and statistical methodology as required
Candidate Requirements
- Advanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment
- Strong experience within Oncology clinical development
- Demonstrated expertise in hematological malignancies, including multiple myeloma, leukemia, and/or lymphoma
- Strong knowledge and practical application of CDISC standards, including SDTM
- Experience performing or overseeing QC of SDTM datasets
📌 Principal Biostatistician (Roma)
🏢 Iqvia
📍 Roma