ph3Principal Statistician, Global Rare Diseases /h3 pIn 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 RD, contributing to high-quality submissions and scientific publications. /p ul liannual premio /li lipension /li liprivate medical insurance /li liremote work options /li liProvide statistical input to Drug Development Programs /li liLead study design, sample size calculations, and randomization plans /li liOversee analyses, reporting, and interpretation of trial data /li liManage statistical activities for clinical trials and interactions with CROs /li liReview abstracts, posters, presentations,



and manuscripts /li liContribute to Clinical Study Reports and regulatory documents /li liPrepare and manage Statistical Analysis Plans and derived datasets /li liLead Data Review Meeting and supervise statistical programmers /li liEnsure compliance with GCP, GCDMP, CFR 21.11 /li liParticipate in regulatory audits/inspections and agency meetings /li liProvide knowledge-sharing and mentorship within the team /li liSupport regulatory submissions via eCTD and respond to queries from authorities /li liDefine and implement SOPs related to statistical activities /li liAssist in recruitment initiatives and uphold safety policies /li liPhD or MSc degree in Statistics /li li10 years of experience in statistics for clinical trials in pharma or CROs /li liStrong knowledge of drug development process and regulatory requirements (ICH/GCP) /li liExpertise in statistical methods for drug development /li liAbility to provide statistical leadership to cross-functional teams /li liStrong communication skills for non-statistical audiences /li liProficiency in CDISC data standards /li liKnowledge of sample size calculation tools /li /ul /p #J-18808-Ljbffr

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