Principal Biostatistician (Therapeutic Areas - Oncology / Vaccines)

📋 Description

• • Serve as a statistical department resource by mentoring biostatisticians and developing training plans or materials for Biostatistics associates, including conducting training sessions for new hires and enhancing the skills of existing personnel.
• • Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work and provide independent review of project outputs from other biostatisticians.
• • Provide end-to-end statistical support across the entire project lifecycle, from protocol development through Clinical Study Report (CSR) preparation.
• • Prepare or oversee the development of Statistical Analysis Plans (SAPs), including creating well-presented mock-ups for tables, listings, and figures, and collaborate with sponsors as needed.
• • Act as Lead Biostatistician for statistical aspects of protocols, including generation of randomization schedules and input into clinical study reports.
• • Create or review programming specifications for analysis datasets, tables, listings, and figures to ensure alignment with statistical objectives and regulatory standards.
• • Review SAS annotated case report forms (CRFs), database design, and other study documentation to verify that protocol criteria are fully met and all required data is captured for high-quality databases and planned analyses.
• • Represent the Biostatistics department on cross-functional project teams, interfacing with other departmental representatives to ensure integrated and efficient project execution.
• • Prepare in advance for internal meetings, actively contribute ideas, and demonstrate respect for the opinions of colleagues to foster collaborative decision-making.
• • Implement company objectives and develop alternative solutions to address business and operational challenges within biostatistics operations.
• • Apply deep expertise in oncology and vaccine therapeutic areas to guide statistical strategy and ensure alignment with regulatory expectations and sponsor needs.
• • Maintain high standards of quality and compliance in all statistical deliverables, ensuring adherence to industry best practices and regulatory guidelines.
• • Contribute to a culture of innovation and continuous improvement by challenging the status quo and driving efficient, patient-centric solutions across drug development and commercialization processes.