Principal Biostatistician – Oncology (FSP -Permanent Homebased)

IQVIA; Paris; À distance; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global leader in clinical research services is seeking an experienced Principal Biostatistician for a permanent remote role. You will lead statistical efforts on global late-phase oncology trials, focusing on regulatory submissions and collaborating with cross-functional teams. The ideal candidate must have a strong background in biostatistics and clinical trials with at least 5 years of experience. Join us to improve cancer treatment outcomes while enjoying flexibility in your work environment.

Prestations

Flexible remote work

Collaborative team environment

Exposure to cutting-edge research

Qualifications

• 5+ years of experience in clinical trials with a focus on oncology.
• Proven experience working on registrational studies and regulatory submissions.
• Strong knowledge of ADaM and SDTM datasets.

Responsabilités

• Lead statistician on global late-phase registration trials.
• Contribute to study design and statistical analysis plans.
• Participate in study team meetings to provide statistical guidance.

Connaissances

Statistical analysis

SAS programming

Communication skills

Regulatory submissions

Formation

Advanced degree in Biostatistics, Statistics, or related field

Outils

CDISC standards

Description du poste

We are seeking an experienced and proactive Principal Biostatistician to join our FSP team, supporting a global pharmaceutical client. This is a permanent, home-based position offering the opportunity to work on late-phase global oncology trials, with a focus on hematology and regulatory submissions.

Overview

Responsibilities

• Serve as the lead statistician on global late-phase registration trials, particularly in oncology (hematology preferred).
• Independently contribute to study design, statistical analysis plans (SAPs), and regulatory submission strategies.
• Participate in study team meetings, providing statistical guidance and collaborating with cross-functional teams.
• Address health authority questions and support responses with appropriate statistical analyses and documentation.
• Perform hands-on statistical programming to derive outputs and summary statistics using ADaM and SDTM datasets.
• Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards.

Required Qualifications

• Advanced degree (Master’s or PhD) in Biostatistics, Statistics, or a related field.
• 5+ years of experience in clinical trials, with a strong focus on oncology (hematology and late-phase preferred).
• Proven experience working on registrational studies and regulatory submissions.
• Strong knowledge of CDISC standards, particularly ADaM and SDTM.
• Proficiency in SAS programming and ability to perform hands-on statistical analyses.
• Excellent communication skills and ability to work independently in a global, cross-functional environment.

Preferred Experience

• Prior involvement in FDA / EMA submissions.
• Experience addressing regulatory agency queries.
• Familiarity with real-world evidence and observational studies is a plus.

Why Join Us?

• Work on high-impact global studies with a focus on improving cancer treatment outcomes.
• Be part of a collaborative and innovative team environment.
• Enjoy the flexibility of remote work with a permanent contract.
• Gain exposure to regulatory strategy and cutting-edge oncology research.

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