Overview
Lead Statistician
As a senior statistician, you will design and implement advanced statistical analyses across all clinical phases.
Responsibilities
- Develop innovative clinical trial designs (Phases I–IV) that ensure efficiency, scientific robustness, and alignment with strategic goals
- Review key trial documentation: protocols, SAPs, CSRs, publications, and more
- Present statistical findings clearly and effectively to internal and external stakeholders
- Provide expert statistical input on regulatory submissions, publications, and responses to health authorities
- Oversee multiple studies within a therapeutic area, ensuring consistency, compliance, and quality
- Manage strong working relationships with CROs, vendors, and alliance partners
- Serve as the biostatistics point of contact across cross-functional project teams, contributing strategic insights throughout the drug development lifecycle
Qualifications
- PhD in Statistics or Biostatistics
- Strong programming skills in SAS, R, or Python
- Proven ability to design and implement advanced statistical analyses
- Understanding of regulatory frameworks; experience with HTA is beneficial
- Experience in rare disease trials is highly desirable
- Collaborative mindset with excellent communication and leadership skills
- Ability to lead, mentor, and guide junior statisticians and cross-functional teams
Why Join Our Team?
- Collaborative science-driven culture
- Influence projects from early development through to regulatory approval
- Flexibility with a hybrid work model based in Italy
- Make a tangible impact on patient outcomes, especially in rare and complex diseases