1 week ago

Principal Biostatistician (Oncology) - FSP

IQVIA

Amsterdam

1 week ago

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Principal Biostatistician needed to provide strategic statistical leadership for Oncology clinical trials, focusing on hematological malignancies. The role involves leading statistical activities, ensuring CDISC compliance, and collaborating with cross-functional teams. Requires advanced experience in a Pharmaceutical, Biotechnology, or CRO environment.

On-siteFull-timePrincipalBiostatisticsOncology

Principal Biostatistician (Oncology) - FSP

Apply

On-siteFull-timePrincipalBiostatistics

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

On-site

Employment Type

Full-time

Experience Level

Principal

Core Qualifications

Technical (Must-have)

BiostatisticsOncologyHematological MalignanciesMultiple MyelomaLeukemiaLymphomaCDISC StandardsSDTMQuality ControlClinical Trial MethodologyStatistical Principles

Soft Skills

CommunicationCollaborationInfluenceLeadership

Preferred Qualifications

Technical (Nice-to-have)

Lead Study StatisticianClinical Trial Statistical DesignStudy PlanningRegulatory SubmissionsStatistical Programming Tools

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

BiostatisticianOncologyClinical TrialsPharmaceuticalCROCDISCSDTMPrincipalFull-timeOn-site

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