Oncology Data Analyst

2 weeks ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €104,911 - €128,935
Lead Biostatistician for Oncology Trials

We are seeking an experienced and proactive Lead Biostatistician to support global pharmaceutical clients in late-phase global oncology trials, with a focus on hematology and regulatory submissions.

Job Responsibilities:

  • Oversee statistical analysis and contribute to study design, statistical analysis plans, and regulatory submission strategies.
  • Collaborate with cross-functional teams, participating in study team meetings and providing statistical guidance.
  • Address health authority questions and support responses with appropriate statistical analyses and documentation.
  • Perform hands-on statistical programming using ADaM and SDTM datasets.
  • Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards.

Requirements:

  • Advanced degree 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 Qualifications:

  • Prior involvement in FDA/EMA submissions.
  • Experience addressing regulatory agency queries.
  • Familiarity with real-world evidence and observational studies is beneficial.

This is a permanent, remote position offering the opportunity to work on high-impact global studies with a focus on improving cancer treatment outcomes. Enjoy flexibility and gain exposure to regulatory strategy and cutting-edge oncology research.

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