Principal Biostatistician
Pubblicato il 15-09-2026 - Iqvia in Italia
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.
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 and related outputs
- Proven ability to work effectively within cross-functional teams and influence key stakeholders
- Excellent verbal and written