Director Biostatistics

Planet Pharma; Remote; GBP 200,000 +; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Director of Biostatistics to lead statistical activities across clinical trials in oncology. This fully remote role emphasizes project leadership and strategic input into study designs. Candidates should have a PhD or MSc in a relevant field and at least 10 years of experience in clinical biostatistics. The position offers a flexible work environment and a collaborative culture focused on innovation and patient impact.

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 cross-functionally with various teams to ensure robust statistical deliverables.

Skills

Statistical analysis

Clinical trial design

Regulatory compliance

Statistical software proficiency (SAS, R)

Scientific writing

Communication

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.