Amsterdam
2 weeks ago
Principal Biostatistician (Oncology) - FSP logo

Principal Biostatistician (Oncology) - FSP

IQVIA

Principal Biostatistician (Oncology) - FSP

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

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