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.
- 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
✔ 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
✔ 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
