Principal Biostatistician (Oncology) - FSP

IQVIA; Roma; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Principal Biostatistician to provide strategic statistical leadership for Oncology clinical development, with emphasis on hematological malignancies such as multiple myeloma, leukemia, and lymphoma. You will collaborate across teams to ensure regulatory-compliant, high-quality statistical outputs throughout development.

Responsibilities include leading trials, overseeing SDTM QC, and communicating complex statistics to diverse stakeholders.

Competenze

• Advanced experience as a Principal Biostatistician in a Pharmaceutical, Biotechnology or CRO environment.
• Extensive Oncology clinical development experience.
• Demonstrated expertise in hematological malignancies including multiple myeloma, leukemia and 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 stakeholders.
• Excellent verbal and written communication of statistical concepts and study results.

Mansioni

• Provide Principal-level Biostatistics leadership for Oncology development programs and studies.
• Lead statistical activities across trials and act as primary statistical representative.
• Review and oversee QC of SDTM datasets and CDISC deliverables.
• Collaborate with Programming, Data Management, Clinical Operations, and Regulatory teams.
• Support interpretation and communication of study results to stakeholders.
• Ensure all statistical deliverables meet quality, regulatory, and timeline expectations.
• Communicate statistical concepts to both technical and non-technical audiences.
• Contribute to study design discussions, protocol development, and statistical methodology.

Conoscenze

Principal Biostatistician

Oncology clinical development

Hematological malignancies

CDISC standards

SDTM

QC of SDTM datasets

Cross-functional collaboration

Statistical methods

Regulatory submissions

Descrizione del lavoro

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.