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 *****
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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