14 set - Emilia-Romagna
Chiesi
OverviewIn 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 / Benefitsflexible working
remote working
relocation support
tax assistance for foreign colleagues
people-care services
continuous training and development
ResponsabilitàDefine 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 fondamentaliAdvanced 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
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