Director Biostatistics

Planet Pharma; Remote; GBP 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company is seeking a Director of Biostatistics, focusing on strategic oversight of oncology clinical trials. This fully remote position requires a PhD or MSc in Biostatistics and a minimum of 10 years of experience in trial biostatistics. Responsibilities include leading statistical strategy, collaborating cross-functionally, and ensuring compliance with regulatory guidelines. The ideal candidate will thrive in a scientifically driven environment and have excellent communication skills. Flexible working hours with occasional travel included.

Qualifications

• 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.

Responsibilities

• Serve as the lead biostatistician on multiple oncology studies ensuring statistical integrity.
• Provide strategic input into protocol design and statistical analysis plans.
• Collaborate with teams to ensure robust statistical deliverables.

Skills

Leadership in statistical strategy

Proficiency in SAS

Communication skills

Scientific writing

Understanding regulatory guidelines

Education

PhD or MSc in Biostatistics, Statistics, or related field

Tools

SAS

R

Job description

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.