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 bonus
- 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
Principal Statistician, Global Rare Diseases datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
