Principal Statistician, Global Rare Diseases

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Principal Statistician, Global Rare Diseases
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.
annual premio pension private medical insurance remote work options 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 ***** Participate in regulatory audits/inspections and agency meetings Provide knowledge-sharing and mentorship within the team Support regulatory submissions via e CTD and respond to queries from authorities Define and implement SOPs related to statistical activities Assist in recruitment initiatives and uphold safety policies Ph D 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 Knowledge of sample size calculation tools #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7clyw1