Overview
In this role you will lead the Global Clinical Development data functions to accelerate and ensure rigorous, compliant drug development. You will shape data strategies, drive innovation with new methods and technologies, and build high-performing, collaborative teams. You will partner with cross-functional groups to ensure high data quality and regulatory readiness across all trial phases. This is an opportunity to influence how data supports clinical decisions and regulatory submissions at a global scale.
Retribuzione / Benefits
- flexible working
- remote working
- relocation support
- tax assistance for foreign colleagues
- people-care services
- continuous training and development
Responsabilità
- Define and execute the data and statistical vision aligned with R&D strategy
- Introduce methodologies and technologies (AI analytics, digital endpoints) to speed up development
- Oversee planning, conduct, and delivery of data management and statistical analysis activities
- Ensure excellence across protocol development, CRF design, data standards, analysis plans, programming, and reporting
- Manage outsourcing strategies and relationships with CROs and technology vendors
- Provide leadership and career development to data management, biostatistics, and programming teams
- Foster a high-performance, collaborative, innovation-driven culture
- Collaborate with Clinical Operations, Regulatory, Medical Affairs, and others to ensure trial execution and data quality
- Represent data functions in governance bodies and external engagements (regulatory, HTA, conferences)
Requisiti fondamentali
- Advanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences, or related discipline
- Minimum 10 years of experience in management or leadership roles in global biometrics
- Experience in both early- and late-phase clinical development in pharma
- Deep knowledge of GCP, ICH, CDISC (SDTM, ADaM) and regulatory requirements
- Expertise in SAS, R, and modern clinical data systems (EDC)
- Familiarity with innovative data approaches (clinical evidence integration, adaptive designs, automation tools)
- Strategic mindset
- Proven change leadership
- Strong communication
- SAS
- R
- EDC systems
Senior Director, Clinical Biometrics & Analytics datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
