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Director Biostatistics
Job in
Leeds, West Yorkshire, ME17, England, UK
Listed on 2025-12-30
Listing for:
Planet Pharma
Full Time
position Listed on 2025-12-30
Job specializations:
-
IT/Tech
Data Security -
Research/Development
Job Description & How to Apply Below
Planet Pharma are seeking highly experienced and strategic Directors of Biostatistics (both Oncology and Non-Oncology) to lead statistical activities across a portfolio of clinical trials, spanning early to late phase development. This is a senior individual contributor role, ideal for someone who thrives in a hands‑on, scientifically driven environment and prefers to focus on project leadership rather than people management.
Key Responsibilities- Serve as the lead biostatistician on multiple oncology studies (Phase I–III), ensuring statistical integrity and regulatory compliance throughout the trial lifecycle.
- Provide strategic input into protocol design, statistical analysis plans (SAPs), and clinical development strategies.
- Collaborate cross‑functionally with clinical, regulatory, data management, and programming teams to ensure robust statistical deliverables.
- Represent biostatistics in internal governance meetings, sponsor interactions, and regulatory submissions.
- Review and interpret statistical outputs, author statistical sections of clinical study reports (CSRs), and contribute to publications and presentations.
- Stay abreast of methodological advances in oncology statistics and apply innovative approaches where appropriate.
- PhD or MSc in Biostatistics, Statistics, or a related field.
- Minimum 10 years of experience in clinical trial biostatistics ideally within a sponsor organization.
- Proven track record of leading statistical strategy for early and late phase trials.
- Deep understanding of regulatory guidelines (e.g., ICH, EMA, MHRA) and experience with submissions.
- Proficiency in statistical software (e.g., SAS, R) and CDISC standards.
- Excellent communication and scientific writing skills.
- Fully remote role based in the UK.
- Flexible working hours with occasional travel for team meetings or sponsor engagements.
- Collaborative, science‑driven culture with a focus on innovation and patient impact.
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