Principal Statistician, Global Rare Diseases

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gngre

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 skills for non-statistical audiences Proficiency in CDISC data standards SAS System proficiency Knowledge of sample size calculation tools English fluent leadership and team collaboration clear communication of complex ideas problem-solving and analytical thinking SAS System CDISC data standards statistical methodologies for clinical trials

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8gngre