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.
🧠 Qualifications & Experience
* 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.
🌍 Work Environment
* 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.