Principal Biostatistician – Oncology (FSP -Permanent Homebased)

IQVIA Argentina; England; Remote; GBP 65,000 - 85,000; Full time

Job summary

A leading global clinical research provider is seeking a Principal Biostatistician to support late-phase global oncology trials. This home-based position involves leading statistical analysis, contributing to study design, and ensuring compliance with regulatory submission standards. Candidates should have an advanced degree in Biostatistics or Statistics, and 5+ years of experience in clinical trials with a focus on oncology. Join a collaborative team aimed at improving cancer treatment outcomes.

Benefits

Permanent contract

Flexible remote work

Collaborative team environment

Qualifications

• 5+ years of experience in clinical trials, focusing on oncology.
• Experience working on registrational studies and regulatory submissions.
• Proficiency in statistical programming and knowledge of ADaM and SDTM.

Responsibilities

• Lead statistician on global late-phase registration trials.
• Independently contribute to study design and SAPs.
• Support regulatory submission strategies and answer health authority questions.

Skills

Statistical analysis

Biostatistics

SAS programming

CDISC standards knowledge

Excellent communication

Education

Advanced degree in Biostatistics or Statistics

Tools

SAS

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