Principal Statistician, Global Rare Diseases

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cb73g

Principal Statistician, Global Rare Diseases
Può ottenere maggiori dettagli sulla natura di questa posizione e sui requisiti per i candidati leggendo quanto segue.

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.

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- 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 xysqume 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

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cb73g