Director Biostatistics

Planet Pharma; Remote; GBP 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company is seeking a Director of Biostatistics to oversee statistical activities for clinical trials in both oncology and non-oncology. This senior role emphasizes project leadership, managing statistical integrity, and regulatory compliance across trials. The ideal candidate will have at least 10 years of relevant experience, a PhD or MSc, and proficiency in statistical software like SAS and R. This position offers flexibility and a collaborative, science-driven work culture.

Benefits

Flexible working hours

Collaborative work culture

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 (Phase I–III).
• Provide strategic input into protocol design and statistical analysis plans (SAPs).
• Collaborate cross‑functionally with clinical, regulatory, data management, and programming teams.

Skills

Leadership in statistical strategy

Regulatory compliance knowledge

Statistical software proficiency

Excellent communication skills

Education

PhD or MSc in Biostatistics 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.