Principal Statistician
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
* 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