Oncology Statistician Leader

3 days ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €111,908 - €137,778

Job Title: Principal Biostatistician – Oncology

About the Role

We are seeking an experienced and proactive Principal Biostatistician to join our 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.

Key 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.
Requirements

To succeed in this role, you will need:

  • An 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.
  • A 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 Qualifications

The following qualifications would be beneficial for this role:

  • Prior involvement in FDA/EMA submissions.
  • Experience addressing regulatory agency queries.
  • Familiarity with real-world evidence and observational studies.
Why Work with Us?

As a valued member of our team, you will have the opportunity to work on high-impact global studies with a focus on improving cancer treatment outcomes. You will be part of a collaborative and innovative team environment, with the flexibility of remote work and a permanent contract. You will gain exposure to regulatory strategy and cutting-edge oncology research, and be able to develop your skills and expertise in a supportive and dynamic environment.

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.

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