Principal Biostatistician (Oncology) - FSP
Pubblicato il 16-09-2026 - Altro in Roma
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 communication skills
Strong understanding of statistical principles and clinical trial methodology
Preferred Qualifications Experience serving as Lead Study Statistician within a cross-functional clinical development team
Knowledge and experience in clinical trial statistical design and study planning
Experience supporting regulatory submissions and interactions with health authorities
Familiarity with advanced statistical programming tools and industry-standard processes
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