Overview
As a statistical leader in Chiesi’s Clinical Development, you guide methodology and analysis across drug development programs. You collaborate with cross-functional teams to ensure rigorous statistics, regulatory compliance, and timely deliverables. You leverage data mining and exploratory analysis to inform decision-making and support publications. This role offers strategic impact on submissions, global regulatory interactions, and advancing innovative therapies.
Retribuzione / Benefits pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
Responsabilità Provide scientifically rigorous statistical expertise to clinical development plans, study design, analysis, and interpretation of results
Ensure quality and timely statistical deliverables across projects, including reviews of vendor work
Coordinate with statisticians on the project to maintain a consistent statistical approach
Contribute to submission plans and interact with regulatory agencies and HTA bodies
Lead preparation of statistical deliverables for regulatory submissions (ISS, ISE, data package)




Maximize data value through data mining and post-hoc analyses; prepare abstracts/posters for publication
Contribute to internal standards, SOPs, and process improvements; participate in trainings and audits
Represent statistics during regulatory inspections and build external collaborations with statistical experts
Requisiti fondamentali Significant experience in statistics applied to clinical trials in pharma or CROs
PhD or MSc in Statistics
Fluent in English
Strong understanding of drug development and regulatory requirements
Proven ability to explore and analyze internal/external data including Real World Data
Experience with regulatory submissions and interactions across geographies
Leadership and influence skills
Problem solving and decision making
Quality orientation
Leadership
Social influence
Problem solving
Statistical methodology for drug development
Regulatory submission preparation (ISS, ISE, eCTD modules)
Data mining and exploratory analysis

📌 Principal Statistician (Parma)
🏢 Chiesi
📍 Parma