Senior Biostatistician – Oncology (FSP -Permanent Homebased)
- Reading
- Permanent
- Full-time
- 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
- 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.
- Prior involvement in FDA/EMA submissions.
- Experience addressing regulatory agency queries.
- Familiarity with real-world evidence and observational studies is a plus.
- 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.