Senior Director, Clinical Biometrics – Analytics

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🕒 May 10

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Logo of Chiesi Group

Chiesi Group

5001 - 10000 employees

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.

📋 Description

• Strategic leadership role within Global Clinical Development, responsible for overseeing Data Management, Biostatistics, and Statistical Programming functions • Drive the vision, execution, and innovation of clinical data strategies across all phases of drug development, ensuring scientific rigor, operational efficiency, and regulatory compliance • Act as responsible manager and high-functioning leader, accountable for building high-performing teams and fostering a culture of collaboration, accountability, and continuous improvement • Define and execute the data and statistical vision in alignment with Global Clinical Development and R&D strategy • Introduce and support new methodologies and technologies (e.g., innovative designs and approaches, AI-based analytics, digital endpoints) to accelerate and optimize clinical drug development • Oversee efficient planning, conduct, and effective delivery of clinical data management and statistical analysis activities • Ensure functional excellence across protocol development, CRF design, data standards, statistical analysis plans, programming, and reporting, and submission dossiers • Provide line management and career development to functional leads and team members in Data Management, Biostatistics, and Statistical Programming • Partner closely with Clinical Operations, Clinical Excellence, Regulatory, Medical Affairs, and other key functions to ensure alignment and seamless trial execution

🎯 Requirements

• Advanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences, or related discipline • Minimum 10 years of experience management or leadership roles in global biometrics • Experience in both early- and late-phase clinical development, preferably in pharmaceutical setting • Deep knowledge of GCP, ICH, CDISC (SDTM, ADaM), and regulatory requirements • Expertise in tools such as SAS, R, and modern clinical data systems (EDC) • Familiarity with innovative data approaches (e.g., clinical evidence integration, adaptive designs, automation tools) considered a strong asset • Strategic mindset with operational discipline • Proven ability to lead change, build teams, and influence across functions and levels • Strong communication, decision-making, and organizational skills • Commitment to quality, compliance, and continuous improvement

🏖️ Benefits

• Flexible working approach • Remote working • Support in the relocation process • Tax assistance service for foreign colleagues • Continuous training, learning and development • Focus on the quality of working environment and collective well-being

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