Director Biostatistics
hace 17 horas
Leeds
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.