Clinical Biostatistics Manager Milano

Clinical Biostatistics Manager
Milano
Lombardia, Milano

Jefferson Wells is looking for a Senior Statistician/Biostatistics Manager on behalf of Italfarmaco (Cinisello Balsamo).

Key Responsibilities • Collaborates in design of innovative and efficient clinical trials (phase I to phase IV), including the selection of study population/endpoints to address study objectives, and contributes to project development strategy • Independently authors and/or reviews protocol, statistical analysis plan, data presentation plan, clinical study reports, associated publications, and other study level documents • Presents summary data and analyses results, in a clear, concise, complete, and transparent manner • Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information • Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area • Manages relationships and interactions with development alliance partners.

• Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Biostatistics activities, manages data currency throughout the trial, and overall monitoring Biostatistics deliverables according to the Service Agreement (SA) • Act as a functional representative and a point of contact for CRO and preferred vendors • Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development and/or real-world research.

• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and medical affairs, market access environments with demonstrated application to study design.

• Ensures that analyses conducted for MA/HEOR are scientifically sound and that the trial design and data collected support conducting the analysis.

• Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process • Compliant with Italfarmaco processes and SOPs and responsible for quality of deliverable • Develops & advises team members on statistical topics • Support the Health Authority inspections, audits, and CAPA implementation • Manages a functional or project budget in alignment with BDS Director • Provides coaching and quality oversight of junior biostatisticians • Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.