Principal Statistician - Ophthalmology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistician - Ophthalmology based in Germany.

This is a senior statistical leadership opportunity supporting clinical development programs in ophthalmology within a fully remote European environment. You will provide statistical expertise across the full clinical trial lifecycle, from protocol development through clinical study reporting and regulatory activities. The role combines hands-on statistical work with project leadership, mentoring, quality oversight, and cross-functional collaboration. You will work closely with clinical, programming, regulatory, and sponsor teams to ensure robust study design and high-quality analyses. You will also contribute to complex projects, integrated analyses, submissions, and potentially regulatory agency interactions. With significant responsibility and autonomy, you will help translate complex statistical concepts into clear insights that support critical healthcare decisions.

Accountabilities: Serve as a senior statistical resource across clinical development projects, providing expertise throughout the study lifecycle from protocol development through the Clinical Study Report (CSR).

Lead or oversee statistical activities for assigned projects, ensuring high-quality deliverables are completed within agreed timelines and according to applicable standards.

Develop, review, and oversee Statistical Analysis Plans (SAPs), including well-structured mock-ups for tables, listings, and figures, and collaborate with sponsors as required.

Act as Lead Biostatistician when assigned, supporting statistical aspects of protocols, randomization schedules, analyses, and clinical study reports.

Provide statistical input into database design, annotated case report forms, analysis datasets, tables, listings, figures, and related programming specifications.

Conduct independent review and quality control of statistical deliverables, ensuring analyses are consistent with approved SAPs, specifications, protocols, and expected results.

Direct and mentor other biostatistics professionals, contribute to training programs, and support the development of statistical capabilities across the department.

Lead complex or multiple projects, including submissions and integrated analyses, and support regulatory agency meetings or responses to statistical questions when needed.

Monitor project milestones, workload, timelines, and resource requirements, proactively communicating risks, scope changes, or delivery challenges to management.

Represent biostatistics on cross-functional project teams, contributing to internal meetings, strategic discussions, and project decision-making.

Participate in Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including charter development and independent statistical oversight, with the potential to serve as a voting statistician.

Support statistical programming activities as required, including R-based analyses and related statistical deliverables.

Ensure project documentation, quality-control records, and statistical programs remain complete, organized, current, and inspection-ready.

Contribute to business development activities, including proposals, budgets, and sponsor bid defense meetings.

Apply relevant SOPs, work instructions, ICH guidelines, and other applicable regulatory requirements throughout project execution.

Requirements

Graduate degree in biostatistics, statistics, or a closely related quantitative discipline.

Extensive experience in clinical trials or an equivalent combination of education and professional experience, with a demonstrated ability to lead multiple projects or programs of studies.

Strong proficiency in R programming and practical experience applying statistical programming techniques in clinical research.

Extensive knowledge of statistical study design, analysis methodologies, clinical research practices, and relevant regulatory requirements.

End-to-end experience supporting clinical trials across the lifecycle, from protocol development and study design through analysis and CSR preparation.

Experience preparing or reviewing Statistical Analysis Plans, statistical specifications, analysis datasets, tables, listings, figures, and related clinical documentation.

Experience with regulatory submissions and interactions with regulatory agencies is highly desirable.

Strong leadership and mentoring capabilities, with the ability to guide biostatisticians and contribute to training and professional development.

Excellent written and verbal communication skills, with the ability to explain complex statistical concepts clearly to technical and non-technical stakeholders.

Strong organizational and prioritization skills, with the ability to manage multiple projects, shifting priorities, deadlines, and competing demands.

Collaborative and proactive approach, with the confidence to contribute ideas, challenge assumptions constructively, and work effectively across multidisciplinary and international teams.

Fluent in English, with strong reading, writing, speaking, and comprehension skills.

Benefits

Fully remote working opportunity within Europe.

Flexible environment designed to support collaboration across distributed international teams.

Competitive compensation and comprehensive total rewards.

Opportunities for career development and professional progression.

Supportive and engaged line management.

Access to technical and therapeutic-area training.

Peer recognition and employee reward programs.

Opportunity to work on complex clinical development programs with a meaningful impact on healthcare and patient outcomes.

Exposure to multidisciplinary teams, global sponsors, and a broad range of clinical research projects.

Opportunities to contribute to innovative statistical approaches, regulatory submissions, and high-impact clinical programs.

An inclusive and collaborative working culture that encourages employees to bring their authentic selves to work.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1