Senior Director, Biostatistics

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Provide strategic statistical leadership for clinical development programs and studies, overseeing everything from design through to regulatory submissions and lifecycle management.

• Inspire, lead, and mentor a small global team of statisticians.

• Direct the statistical design, analysis, interpretation, and communication of clinical trial data.

• Serve as a senior Principal Statistician for key development projects as necessary.

• Review protocols, SAPs, and CSRs while offering guidance on regulatory submissions, briefing documents, and responses to inquiries from health authorities.

• Supervise statistical deliverables to ensure they meet quality, consistency, and timely execution standards.

• Ensure adherence to regulatory requirements, GCP, ICH guidelines, and company standards.

• Collaborate with cross-functional stakeholders and represent Biostatistics in strategic discussions.

• Foster capability building and innovation to address current and future business needs.

• Enhance the visibility and influence of Biostatistics internally and externally through joint authorship of publications and presentations.

⛳️ Requirements

• PhD or Master’s degree in Statistics, Biostatistics, Mathematics, or a related field.

• Significant experience in clinical drug development within pharmaceutical, biotechnology, or CRO settings.

• Extensive biostatistical experience as a project statistician or principal statistician within the pharmaceutical sector across various therapeutic areas.

• Strong background in supporting Phase II–IV clinical trials and regulatory submissions.

• Experience in leading, mentoring, and developing statisticians in a global pharmaceutical or CRO environment.

• A demonstrable record of collaboration on external publications is preferred.

• In-depth understanding of clinical trial statistical methodologies.

• Proficient in SAS and/or R.

• Familiarity with CDISC standards, including SDTM and ADaM.

• Knowledge of electronic submission standards and regulatory review processes.

• Comprehensive understanding of global regulatory submission expectations.

• Proven history of direct interaction with regulatory agencies at a senior level.

• An inclusive leader with a proactive and collaborative approach, comfortable operating in a complex, cross-functional environment, and able to lead by example as a hands-on senior principal statistician.

🏝️ Benefits

• Competitive salaries.

• Comprehensive benefits package.

• Inclusive workplace environment.

• Equal Opportunity Employer.