Senior Director, Clinical Biometrics – Analytics

This is a fully remote position, open to applicants in Italy.

📋 Description

• This position offers strategic leadership within Global Clinical Development, overseeing functions such as Data Management, Biostatistics, and Statistical Programming.

• You will drive the vision, implementation, and innovation of clinical data strategies throughout all drug development phases, ensuring scientific rigor, operational efficiency, and adherence to regulatory standards.

• Serve as a responsible manager and effective leader, accountable for cultivating high-performing teams and promoting a culture of collaboration, accountability, and ongoing improvement.

• Define and implement the data and statistical vision in alignment with the strategies of Global Clinical Development and R&D.

• Introduce and support new methodologies and technologies (such as innovative designs, AI-based analytics, and digital endpoints) to enhance and expedite clinical drug development.

• Manage efficient planning, execution, and successful delivery of clinical data management and statistical analysis activities.

• Ensure excellence across protocol development, CRF design, data standards, statistical analysis plans, programming, reporting, and submission dossiers.

• Provide line management and career development opportunities for functional leads and team members in Data Management, Biostatistics, and Statistical Programming.

• Collaborate closely with Clinical Operations, Clinical Excellence, Regulatory, Medical Affairs, and other key functions to ensure alignment and smooth execution of trials.

⛳️ Requirements

• An advanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences, or a related field is required.

• A minimum of 10 years of experience in management or leadership roles within global biometrics is essential.

• Experience in both early- and late-phase clinical development, preferably within a pharmaceutical context.

• Extensive knowledge of GCP, ICH, CDISC (SDTM, ADaM), and regulatory guidelines.

• Proficiency in tools such as SAS, R, and modern clinical data systems (EDC).

• Familiarity with innovative data methodologies (e.g., clinical evidence integration, adaptive designs, automation tools) is considered a significant advantage.

• A strategic mindset coupled with operational discipline.

• Proven capability to lead change, build teams, and influence across various functions and organizational levels.

• Exceptional communication, decision-making, and organizational skills.

• A strong commitment to quality, compliance, and continuous improvement.

🏝️ Benefits

• Flexible working arrangements.

• Options for remote work.

• Support provided for the relocation process.

• Tax assistance services available for international colleagues.

• Opportunities for continuous training, learning, and professional development.

• Emphasis on enhancing the quality of the working environment and overall team well-being.