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 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

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

Knowledge of sample size calculation tools

#J-18808-Ljbffr

📌 Principal Statistician, Global Rare Diseases (Parma)
🏢 Altro
📍 Parma