19 set - Parma
Chiesi
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
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