Principal Biostatistician (Oncology) - FSP

Principal Biostatistician (Oncology) - FSPFrankfurt am Main, Germany | Home-basedAs 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 requiredCandidate RequirementsAdvanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environmentStrong experience within Oncology clinical developmentDemonstrated expertise in hematological malignancies, including multiple myeloma, leukemia, and/or lymphomaStrong knowledge and practical application of CDISC standards, including SDTMExperience performing or overseeing QC of SDTM datasets and related outputsProven ability to work effectively within cross-functional teams and influence key stakeholdersExcellent verbal and written communication skillsStrong understanding of statistical principles and clinical trial methodologyPreferred QualificationsExperience serving as Lead Study Statistician within a cross-functional clinical development teamKnowledge and experience in clinical trial statistical design and study planningExperience supporting regulatory submissions and interactions with health authoritiesFamiliarity with advanced statistical programming tools and industry-standard processes IQVIA