Expert Statistician

The Expert Statistician will provide senior-level statistical expertise to support AAVantgarde Bio’s clinical development programs. This role involves hands-on statistical programming, advanced methodological expertise, and independent scientific judgment, working closely with cross-functional teams. A strong focus will be placed on ophthalmology clinical trials, ensuring analyses are scientifically rigorous and aligned with regulatory expectations. Goals include strategic statistical leadership, designing and interpreting clinical trial data, ensuring accurate deliverables, and acting as a statistical thought partner.

Must Have

• Provide senior statistical expertise for clinical trial design, analysis, and interpretation
• Define statistical strategies including estimands, sample size, interim analyses
• Perform hands-on statistical programming and review of analysis datasets, tables, figures, and listings
• Apply advanced statistical methodologies and ensure alignment with regulatory expectations
• Support the definition, analysis, and interpretation of ophthalmology-specific clinical endpoints
• Ensure high-quality, accurate, and inspection-ready statistical deliverables
• Collaborate closely with Clinical, Medical, Regulatory, Data Management, and Biometrics teams
• Contribute to statistical sections of protocols, SAPs, clinical study reports, and regulatory documents
• Act as a statistical thought partner, clearly communicating results and implications to non-statistical stakeholders

Good to Have

• Prior experience in ophthalmology or rare diseases
• Experience with external or historical control data
• Exposure to Bayesian or simulation-based methods

Perks & Benefits

• Health insurance
• Psychotherapy coverage
• Sport coverage
• Learning budget
• 18 business days of paid vacation days per year
• Paid sick leaves
• All public holidays are paid days off

About the Client & the Project

AAVantgarde Bio is an international clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases. The company has created two proprietary technologies that enable the delivery of large genes into human cells, overcoming one of the major limitations of traditional gene therapy approaches. These platforms are already being validated in clinical trials, with the potential to expand into multiple disease areas beyond ophthalmology. Headquartered in Milan, AAVantgarde operates with a growing international team and a strong focus on translating advanced science into real patient impact. The company was founded by Professor Alberto Auricchio, a globally recognised pioneer in gene therapy.

• Founded: 2021
• Series B startup

About the Role

The Expert Statistician will provide senior-level statistical expertise to support AAVantgarde Bio’s clinical development programs. This role combines hands-on statistical programming, advanced methodological expertise, and independent scientific judgement, working closely with cross-functional teams across Clinical, Medical, Regulatory, Data Management, and Biometrics.

A strong focus will be placed on ophthalmology clinical trials and endpoints, ensuring analyses are scientifically rigorous, clinically interpretable, and aligned with regulatory expectations.

Position Goals:

• Provide strategic and hands-on statistical leadership across clinical development programs
• Design, analyse, and interpret clinical trial data to support high-quality scientific and business decisions
• Ensure statistical deliverables are accurate, inspection-ready, and aligned with regulatory standards
• Act as a trusted statistical thought partner across the organisation

Responsibilities:

• Provide senior statistical expertise for the design, analysis, and interpretation of clinical trials across clinical development programs
• Define statistical strategies including estimands, sample size, interim analyses, and analytical approaches
• Perform hands-on statistical programming and review of analysis datasets, tables, figures, and listings
• Apply advanced statistical methodologies and ensure alignment with regulatory expectations
• Support the definition, analysis, and interpretation of ophthalmology-specific clinical endpoints
• Ensure high-quality, accurate, and inspection-ready statistical deliverables
• Collaborate closely with Clinical, Medical, Regulatory, Data Management, and Biometrics teams
• Contribute to statistical sections of protocols, SAPs, clinical study reports, and regulatory documents
• Act as a statistical thought partner, clearly communicating results and implications to non-statistical stakeholders

Requirements:

• Senior-level expertise in clinical trial statistics within biotech or pharmaceutical environments
• Strong hands-on statistical programming experience
• Deep understanding of advanced statistical methodologies
• Experience supporting regulatory submissions and inspection-ready deliverables (FDA / EMA)
• Ability to work independently in a fast-paced, evolving organisation

Nice-to-have

• Prior experience in ophthalmology or rare diseases
• Experience with external or historical control data
• Exposure to Bayesian or simulation-based methods

Soft Skills

• High attention to detail and scientific integrity
• Clear communication of complex statistical concepts to non-statistical audiences
• Proactive, collaborative, and intellectually curious mindset
• Ability to manage changing priorities and tight timelines

Interview Steps

1. GT interview with Recruiter

2. Client interview

3. Final interview

We go beyond usual perks… By working with us, you will get:

• Health insurance.
• Psychotherapy coverage.
• Sport coverage.
• Learning budget.
• 18 business days of paid vacation days per year
• Paid sick leaves.
• All public holidays are paid days off.

GT working model:

You will work directly with a client through our Extended Team model. We try to do things differently and put our efforts into integrating you as deeply as possible into the client’s team. You work with the same tools and technologies as they do and are managed directly by the client without any intermediary in between. We help you build relationships and create an environment where you genuinely feel like a member of the client’s team. We also encourage trips to a client and join teambuilding and after-work activities. Our Extended Team model is focused on long-term projects that last over several years.