Principal Biostatistician - Oncology (FSP -Permanent Homebased)

IQVIA, Inc.; Reading; Remote; GBP 60,000 - 85,000; Full time

Job summary

A global leader in clinical research services is seeking a Principal Biostatistician to lead late-phase oncology trials from a remote setting. The role demands a strong background in biostatistics and extensive experience in regulatory submissions, where you will leverage your expertise to deliver high-impact studies aimed at improving cancer treatments. Join a collaborative team to make a difference while enjoying the flexibility and benefits of remote work.

Benefits

Collaborative and innovative team environment

Flexibility of remote work

Exposure to cutting-edge oncology research

Qualifications

• 5+ years of experience in clinical trials with oncology focus.
• Strong knowledge of CDISC standards (ADaM, SDTM).
• Proven experience in regulatory submissions.

Responsibilities

• Serve as lead statistician on global late-phase registration trials.
• Contribute to study design and statistical analysis plans.
• Perform hands-on statistical programming using ADaM and SDTM datasets.

Skills

Statistical analysis

Statistical programming

Communication

Education

Master's or PhD in Biostatistics, Statistics or related field

Tools

SAS

Job description

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.

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

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 https://jobs.iqvia.com