Overview In this role you will provide statistical leadership across drug development programs, guiding study design, analysis, and regulatory submissions. You will collaborate with cross-functional teams to ensure rigorous, fit-for-purpose data interpretation and communicate complex results to non-statistical stakeholders. You will oversee statistical activities in clinical trials, liaising with CROs and regulatory agencies. This is an impact-driven position within Chiesi’s R&D;, contributing to high-quality submissions and scientific publications. Retribuzione / Benefits * annual premio * pension * private medical insurance * wellbeing programme * flexible benefits programme * remote work options Responsabilità * Provide statistical input to Drug Development Programs * Lead study design, sample size calculations, and randomization plans * Oversee analyses, reporting, and interpretation of trial data * Manage statistical activities for clinical trials and interactions with CROs * Review abstracts, posters, presentations,



and manuscripts * Contribute to Clinical Study Reports and regulatory documents * Prepare and manage Statistical Analysis Plans and derived datasets * Lead Data Review Meeting and supervise statistical programmers * Ensure compliance with GCP, GCDMP, CFR 21.11 * Participate in regulatory audits/inspections and agency meetings * Provide knowledge-sharing and mentorship within the team * Support regulatory submissions via eCTD and respond to queries from authorities * Define and implement SOPs related to statistical activities * Assist in recruitment initiatives and uphold safety policies Requisiti fondamentali * PhD or MSc degree in Statistics * >10 years of experience in statistics for clinical trials in pharma or CROs * Strong knowledge of drug development process and regulatory requirements (ICH/GCP) * Expertise in statistical methods for drug development * Ability to provide statistical leadership to cross-functional teams * Strong communication s

📌 Principal Statistician, Global Rare Diseases (Parma)
🏢 Chiesi
📍 Parma