Principal Statistician

23 ore fa

parma, emilia romagna, Italia Chiesi Tempo pieno
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