Principal Biostatistician (Integrated analysis experience required) EU based

Salary

Core Qualifications

Preferred Qualifications

Key Responsibilities

• •Serves 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 enhance the skills of existing personnel.
• •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 biostatisticians in the department.
• •Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• •Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• •May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• •Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• •Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
• •Implements company objectives, and creates alternative solutions to address business and operational challenges.
• •Interfaces with other departmental project team representatives as biostatistics representative on project teams.
• •Conducts and participates in verification and quality control of project deliverables.
• •May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions.
• •Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management.
• •Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• •Provides statistical programming support as needed.
• •May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
• •Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• •Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs.
• •Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• •Performs other work-related duties as assigned.
• •Minimal travel may be required.