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Form of workResponsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Lead and develop a group of statisticians and SAS Programmers.
Analysis Services - Carry out statistical analyses and provide direction to programmers, using standard software packages to interpret and translate results within a statistical framework into biomedical terms and prepare statistical data results for inclusion in reports and research papers that meet trial, organizational and regulatory best practices, and standards.
- Working in conjunction with the Director of Academic Research, convert and present new and novel biometrical trial technologies, processes and findings into publishable and promotable scientific processes and results.
- Provide statistical expertise and guidance based on established methodologies throughout the project life cycle in the areas of study policies, protocols, implementation timelines and processes, data interpretation and publication of results. Work with data management team to ensure data captured incorporates and corresponds to project protocols and requirements.
- Prepare statistical analysis plan and oversee project data collection, management, and analysis, with input from the project teams, that incorporates the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.
- Assist medical director(s) and/or technical writers by preparing statistical section of study report, publications and/or presentations ensuring statistical analyses adheres to trial, sponsor, organizational and regulatory requirements, and best practices.
- Assign/schedule studies and tasks to functional unit to ensure project needs are met.
- Responsible for performance management (staff evaluation, performance improvement and lost time management) of direct reports.
- Provide direction and support to project financial coordinators and promote team development by providing coaching, mentoring, and training.
- Develop and deliver ongoing training on document user systems, document naming and department Quality System processes to peers and stakeholders, including new employee orientation.
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