Principal Statistician, Global Rare Diseases
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* 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
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