1 week ago

Principal Biostatistician (Oncology) - FSP

IQVIA

Amsterdam

1 week ago

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Principal Biostatistician needed for Oncology clinical trials at IQVIA, focusing on hematological malignancies. Requires advanced experience in biostatistics within pharma/biotech/CRO and strong knowledge of CDISC standards. Remote position based in Amsterdam.

RemoteFull-timePrincipalBiostatisticsOncology

Principal Biostatistician (Oncology) - FSP

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RemoteFull-timePrincipalBiostatistics

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

BiostatisticsOncologyHematological malignanciesMultiple myelomaLeukemiaLymphomaCDISC standardsSDTMQuality ControlClinical trial methodologyStatistical ProgrammingData ManagementClinical OperationsRegulatory submissionsCross-functional collaboration

Soft Skills

LeadershipCommunicationCollaborationInfluenceProblem-solving

Preferred Qualifications

Technical (Nice-to-have)

Lead Study StatisticianClinical trial statistical designStudy planningHealth authority interactionsAdvanced statistical programming

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

Principal BiostatisticianOncologyHematological malignanciesCDISCSDTMClinical trialsPharmaceuticalBiotechnologyCRORemote

Core Qualifications

Technical (Must-have)

Soft Skills

LeadershipCommunicationCollaborationInfluenceProblem-solving

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