Principal Biostatistician (Oncology) - FSP

IQVIA; Frankfurt; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

IQVIA seeks a Principal Biostatistician to provide strategic statistical leadership for Oncology clinical trials, with a focus on hematological malignancies such as multiple myeloma, leukemia, and lymphoma. You will collaborate across functions to ensure high-quality statistical support throughout development and regulatory processes.

The role emphasizes leadership, CDISC/SDTM expertise, and clear communication with both technical and non-technical audiences, across a full development lifecycle.

Qualifikationen

• Advanced experience as a Principal Biostatistician in pharma/biotech/CRO.
• Expertise in oncology development and hematological malignancies.
• Strong knowledge of CDISC standards and SDTM datasets.
• Ability to lead statistical activities across trials and programs.
• Excellent communication and stakeholder influence.

Aufgaben

• Provide Principal-level leadership for oncology development programs.
• Lead statistical activities and act as primary statistical representative.
• Review QC of SDTM datasets and deliverables for CDISC compliance.
• Collaborate with cross-functional teams to ensure timely outputs.
• Interpret and communicate study results to stakeholders.
• Ensure quality, regulatory compliance, and timelines.

Kenntnisse

Biostatistics leadership

Oncology clinical development

CDISC standards

SDTM

Cross-functional collaboration

Tools

CDISC SDTM QC

Jobbeschreibung

As 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 required

Candidate Requirements

• Advanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment
• Strong experience within 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 QC 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

Preferred Qualifications

• 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.