Principal Biostatistician (Oncology)

Job summary

The role involves providing strategic statistical leadership for Oncology clinical trials, particularly focusing on hematological malignancies such as multiple myeloma, leukemia, and lymphoma. The Principal Biostatistician will collaborate with cross-functional teams to ensure high-quality statistical support throughout the clinical development lifecycle, adhering to regulatory and industry standards.

Qualifications

• Advanced experience as a Principal Biostatistician in a Pharmaceutical, Biotechnology, or CRO environment.
• Strong experience in 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 quality control 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.

Responsibilities

Preferred Qualifications

• 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.
• 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.