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Senior Biostatistician – Oncology (FSP -Permanent Homebased)

IQVIA

Reading

Remote

GBP 50,000 - 75,000

Full time

30+ days ago

Job summary

A leading global provider of clinical research services is seeking a Senior Biostatistician for a permanent home-based role. You will lead statistical efforts on late-phase oncology trials, focusing on hematology and regulatory submissions. This role offers the opportunity to make significant contributions to impactful global studies while working in a flexible, innovative environment.

Benefits

Flexible remote work
Collaborative team environment
Exposure to cutting-edge oncology research

Qualifications

  • 5+ years of experience in clinical trials with a focus on oncology.
  • Strong knowledge of CDISC standards and regulatory submissions.
  • Proven ability to perform hands-on statistical programming.

Responsibilities

  • Lead statistician for global late-phase registration trials.
  • Contribute to study design, statistical analysis plans, and regulatory submissions.
  • Perform statistical programming and ensure compliance with regulations.

Skills

Statistical analysis
SAS programming
Communication

Education

Master’s or PhD in Biostatistics or Statistics

Tools

ADaM
SDTM

Job description

We are seeking an experienced and proactive Senior 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

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