• Leading projects across multiple studies or programs • Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects • Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR • Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures • Collaborates with the sponsor, if required • May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report • Coordinates the activities of other biostatistics and statistical programming 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 • 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 and all data is captured as required to support a high quality database and the planned analysis • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications • Implements company objectives, and create alternative solutions to address business and operational challenges • Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives • 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 • Identifies out of scope tasks and escalates to management • Provides statistical programming support as needed • May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician • May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor • Maintains well organized, complete, and up-to-date project documentation, and 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 • Coaches and mentors other Biostatistics staff. • Performs other work-related duties as assigned.