Director Biostatistics - Ophthalmology (Retina)

Skills Alliance; España; Remote; EUR 120,000 - 180,000; Full time

Job summary

Skills Alliance is seeking a Director, Biostatistics to lead statistical strategy across clinical development, with a focus on ophthalmology retina programs. This remote EU role reports to the Chief Medical Officer.

You will oversee study design, analysis planning, regulatory submissions, and integrate stats with Clinical Operations, Regulatory Affairs, and Medical Writing to ensure timely, high-quality evidence.

Qualifications

• Master’s or PhD in Statistics, Biostatistics, Mathematics, or a related field.
• 10+ years of progressive biostatistics experience in biotech, pharma, or clinical research.
• Proven leadership experience in statistical strategy for clinical development.
• Strong background in complex study designs and advanced statistical methodologies.
• Deep understanding of statistical theory and its application to trial design and analysis.
• Strong proficiency in SAS and regulatory submission experience.
• Excellent communication for technical and non-technical audiences.
• Collaborative with global teams.
• Fluency in English.
• Ophthalmology/ Retina experience is non negotiable.

Responsibilities

• Lead statistical strategy across early- and late-phase programs.
• Guide study design, endpoint selection, and sample size justification.
• Develop evidence generation strategies and analysis plans.
• Represent biostatistics in cross-functional meetings and regulatory discussions.
• Mentor biostatistics team members and build a high-performing function.
• Ensure timely delivery of outputs: analysis plans, tables, figures, listings, reports.
• Collaborate with Clinical Operations, Regulatory Affairs, and Medical Writing.
• Manage external CROs and vendor statistical teams.
• Support regulatory interactions and publications.

Skills

Leadership

Biostatistics

Study design

Regulatory strategy

Communication

Team mentoring

Education

Master’s degree in Statistics/Biostatistics

PhD in Statistics or related field

Tools

SAS

Job description

Director, Biostatistics (Ophthalmology - Retina)

Location: Remote in EU

Department: Clinical

Reporting to: Chief Medical Officer

Employment Type: Full-time

About the role

We are seeking a Director, Biostatistics to lead the strategic planning and oversight of statistical activities across all phases of clinical development. In this role, you will shape statistical strategy, guide trial design and analysis planning, and ensure regulatory alignment across programs. You will serve as a key statistical partner to cross-functional teams, external collaborators, and health authorities, helping drive high-quality, timely evidence generation.

What you’ll do

• Lead statistical strategy and direction across early- and late-phase clinical programs.
• Contribute to development plans and evidence generation strategies.
• Represent biostatistics in cross-functional meetings, boards, and regulatory discussions.
• Guide study design, endpoint selection, sample size justification, analysis plans, and interpretation of results.
• Bring forward innovative statistical approaches where appropriate, including adaptive designs, modeling, and Bayesian methods.
• Lead, mentor, and develop biostatistics team members where applicable, helping build a high-performing function.
• Support the development of best practices and statistical SOPs.
• Ensure accurate and timely delivery of statistical outputs, including analysis plans, tables, figures, listings, and reports.
• Partner with Clinical Operations, Regulatory Affairs, and Medical Writing to keep statistical strategy aligned across studies.
• Manage and liaise with external CROs and vendor statistical teams.
• Support regulatory interactions and contribute to scientific publications and presentations.

What we’re looking for

• Master’s or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative field.
• 10+ years of progressive biostatistics experience in biotech, pharma, or clinical research.
• Proven leadership experience in statistical strategy for clinical development.
• Strong background in complex study designs and advanced statistical methodologies.
• Deep understanding of statistical theory and its application to clinical trial design and analysis.
• Strong proficiency in statistical software, including SAS.
• Experience with regulatory submissions and statistical components of regulatory dossiers.
• Excellent communication skills, with the ability to translate complex statistical concepts for technical and non-technical audiences.
• Collaborative approach and experience working across global teams.
• Strong organizational, strategic thinking, and problem-solving skills.
• Fluency in English, spoken and written.
• Ophthalmology/ Retina experience is non negotiable