Senior Director, Clinical Biometrics

3 giorni fa

Parma, Italia Chiesi Group A tempo pieno

Who we are looking for Strategic leadership role within Global Clinical Development, responsible for overseeing Data Management, Biostatistics, and Statistical Programming functions. The position drives the vision, execution, and innovation of clinical data strategies across all phases of drug development, ensuring scientific rigor, operational efficiency, and regulatory compliance. This is what you will do You will be responsible for Strategic Direction & Innovation Define and execute the data and statistical vision in alignment with Global Clinical Development and R&D strategy. innovative designs and approaches, AI‑based analytics, digital endpoints) to accelerate and optimize clinical drug development. Ensure data and evidence generation capabilities evolve with industry trends and internal needs. Functional & Operational Oversight 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. Leadership & People Management Provide line management and career development to functional leads and team members in Data Management, Biostatistics, and Statistical Programming. Build technical capabilities, foster talent development, and promote a high‑performance, collaborative and innovation‑oriented culture. Cross‑Functional Collaboration Partner closely with Clinical Operations, Clinical Excellence, Regulatory, Medical Affairs, and other key functions to ensure alignment and seamless trial execution. Act as a strategic contributor in clinical study design, development plans and submission dossiers, ensuring statistical and data quality excellence, and supporting data democratization. Represent data and statistical functions in internal governance bodies and external engagements, including with regulatory bodies, conferences, thought leaders and HTA bodies where required. You will need to have 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. 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., Commitment to quality, compliance, and continuous improvement. Location Flexible location within Europe, with the possibility of remote working. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well‑being. That is why we offer a flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people‑care services. #

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