OverviewIn 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 bonuspensionprivate medical insurancewellbeing programmeflexible benefits programmeremote work options

Responsabilità

Provide statistical input to Drug Development ProgramsLead study design, sample size calculations, and randomization plansOversee analyses, reporting, and interpretation of trial dataManage statistical activities for clinical trials and interactions with CROsReview abstracts, posters, presentations,



and manuscriptsContribute to Clinical Study Reports and regulatory documentsPrepare and manage Statistical Analysis Plans and derived datasetsLead Data Review Meeting and supervise statistical programmersEnsure compliance with GCP, GCDMP, CFR 21.11Participate in regulatory audits/inspections and agency meetingsProvide knowledge-sharing and mentorship within the teamSupport regulatory submissions via eCTD and respond to queries from authoritiesDefine and implement SOPs related to statistical activitiesAssist 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 CROsStrong knowledge of drug development process and regulatory requirements (ICH/GCP)Expertise in statistical methods for drug developmentAbility to provide statistical leadership to cross-functional teamsStrong communication skills for non-statistical audiencesProficiency in CDISC data standardsSAS System proficiencyKnowledge of sample size calculation toolsEnglish fluentleadership and team collaborationclear communication of complex ideasproblem-solving and analytical thinkingSAS SystemCDISC data standardsstatistical methodologies for clinical trials

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