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 (Reggio Emilia)
🏢 Chiesi
📍 Reggio Emilia