Principal Biostatistician - Future Roles (UK)

This role is a senior statistical leadership position responsible for overseeing and mentoring biostatisticians, ensuring high-quality statistical analyses, and supporting clinical trials from protocol design through regulatory submission.

Acts as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.

Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor as required and is responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.

Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and that all data is captured to support a high-quality database and planned analysis. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other statisticians in the department.

Implements company objectives and creates alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing with other departmental project team representatives and preparing for internal meetings, contributing ideas, and demonstrating respect for opinions of others.

Conducts and participates in verification and quality control of project deliverables, ensuring output meets expected results and is consistent with the analysis described in the SAP and specifications. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities, adapts to timeline or priority changes, and proactively communicates any difficulties with meeting these timelines to biostatistics management.

Monitors progress on study activities against agreed-upon milestones and ensures project deliverables are met on time. Identifies out-of-scope tasks and escalates to management. Provides statistical programming support as needed.

May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician; may serve as a voting statistician on DSMBs and/or DMCs.

Leads projects involving integrated analyses, attends regulatory agency meetings, or responds to questions to support the statistical analysis results of clinical trials on behalf of the sponsor. Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines such as ICH.

Maintains well-organized, complete, and up-to-date project documentation, as well as verification/quality control documents and programs, ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.

Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Performs other work-related duties as assigned. Minimum travel may be required.