Principal Biostatistician – Oncology (FSP -Permanent Homebased)

IQVIA; Reading; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading global clinical research organization is seeking a Principal Biostatistician to join its FSP team. This permanent, home-based position focuses on late-phase global oncology trials, particularly in hematology and regulatory submissions. Candidates should have an advanced degree and at least 5 years of experience in clinical trials, with strong knowledge of CDISC standards and proficiency in SAS programming. The role offers the chance to work on high-impact global studies and the flexibility of remote work.

Benefits

Flexible remote work

Collaborative team environment

Exposure to cutting-edge oncology research

Qualifications

• Advanced degree (Master’s or PhD) in Biostatistics, Statistics, or a related field.
• 5+ years of experience in clinical trials, with a focus on oncology.
• Proven experience working on registrational studies and regulatory submissions.

Responsibilities

• Serve as lead statistician on global late-phase registration trials.
• Independently contribute to study design and statistical analysis plans.
• Provide statistical guidance and collaborate with cross-functional teams.

Skills

Biostatistics

SAS programming

Statistical analysis

Clinical trials

Regulatory submissions

Education

Master’s or PhD in Biostatistics or Statistics

Tools

ADaM

SDTM

Job description

We are seeking an experienced and proactive Principal Biostatisticianto join our FSP team, supporting a global pharmaceutical client. This is apermanent, home-basedposition offering the opportunity to work onlate-phase global oncology trials, with a focus onhematologyandregulatory submissions.

Key Responsibilities

• Serve as thelead statisticianon globallate-phase registration trials, particularly in oncology (hematology preferred).
• Independently contribute tostudy design,statistical analysis plans (SAPs), andregulatory submission strategies.
• Participate instudy team meetings, providing statistical guidance and collaborating with cross-functional teams.
• Addresshealth authority questionsand support responses with appropriate statistical analyses and documentation.
• Performhands-on statistical programmingto derive outputs and summary statistics usingADaMandSDTMdatasets.
• Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards

Required Qualifications

• Advanced degree (Master’s or PhD) inBiostatistics,Statistics, or a related field.
• 5+ yearsof experience in clinical trials, with a strong focus ononcology(hematology and late-phase preferred).
• Proven experience working onregistrational studiesandregulatory submissions.
• Strong knowledge ofCDISC standards, particularlyADaMandSDTM.
• Proficiency inSASprogramming 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 inFDA/EMA submissions.
• Experience addressingregulatory agency queries.
• Familiarity withreal-world evidenceandobservational studiesis a plus.

Why Join Us?

• Work onhigh-impact global studieswith a focus on improving cancer treatment outcomes.
• Be part of acollaborative and innovativeteam environment.
• Enjoy theflexibility of remote workwith a permanent contract.
• Gain exposure toregulatory strategyandcutting-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