The Role
Provide biostatistical support across clinical trial lifecycle: study design, statistical analysis, SAPs, data management alignment, report/publication preparation, and act as SME to project teams and external stakeholders.
Summary Generated by Built In
Responsible 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.
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.
Academic Research Support
- 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.
Project Support
- 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.
Statistical Analysis/Data Collection Planning
- 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.
Study Report Support
- 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.
Warning
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Skills Required
- Apply biostatistical methods to support clinical trials (planning, design, analysis, reporting)
- Prepare statistical analysis plans and oversee project data collection and management
- Perform statistical analyses and direct programmers using standard statistical software packages
- Provide statistical expertise and guidance to project teams, auditors, and external stakeholders
- Prepare statistical sections of study reports, publications, and presentations per regulatory standards
- Collaborate with data management, medical directors, and academic research leadership to translate findings
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The Company
What We Do
From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.
