Overview
The Biostatistician is an individual contributor responsible for supporting the application of statistical methods to the design, analysis, and reporting of global clinical research studies. This role works under guidance to address the statistical needs of clinical and regulatory projects, contributing to study execution and the development of clinical evidence on behalf of the Cook organization.
Responsibilities
- Follow and adhere to company and team policies, procedures, and regulatory requirements
- Maintain all required training and actively pursue ongoing professional development
- Ensure accuracy and quality of statistical work through peer review and collaboration prior to finalization
- Apply statistical principles and methodology to support the design, execution, analysis, interpretation, and documentation of clinical studies
- Contribute to statistical sections of clinical study protocols, reports, and other study documentation
- Provide statistical support for bench and animal studies, as applicable, including analysis and interpretation of data
- Manage assigned workload to meet project timelines and deliverables
- Communicate regularly with team leadership on project status, progress, and risks
- Support statistical activities across the clinical study lifecycle in collaboration with cross-functional team members
- Collaborate with clinical, regulatory, and scientific team members to maintain statistical representation throughout assigned studies
- Develop a foundational understanding of relevant clinical areas, including medical procedures, physiology, disease processes, and imaging techniques
- Build working knowledge of the clinical study process and applicable global regulations
- Develop and maintain proficiency in statistical programming
- Develop and apply data visualization techniques and foundational real-world data strategies
- Interpret and communicate statistical methods and results clearly to non-statistical audiences
- Maintain reliable attendance, punctuality, and effective participation in team activities
- Contribute to a collaborative team environment and continuous improvement of statistical practices
Qualifications
- Master's degree in Statistics, Biostatistics, or similar technical degree
- Proficiency in statistical programming using SAS or R
- Understanding and application of statistical methods, including principles of experimental design
- Ability to transform, analyze, summarize, and present data effectively using appropriate tools and techniques
- Proficiency in Microsoft Office tools for analysis, documentation, and reporting
- Foundational understanding of artificial intelligence (AI) and data concepts, including the ability to critically evaluate AI-generated outputs
- Ability to leverage approved AI tools to improve workflows and analytical efficiency
- Awareness of potential bias, limitations, and risks in data and AI-driven analyses, with the ability to communicate findings responsibly
- Strong critical thinking and problem-solving skills with attention to detail
- Ability to apply logical reasoning to evaluate data, identify issues, and support sound conclusions
- Ability and willingness to work in a collaborative, team-based environment
- Receptiveness to direction and feedback from team leadership to ensure alignment and efficient workflow
- Strong organizational skills with the ability to manage multiple tasks and priorities
- Capacity to handle multiple projects and meet deadlines in a structured environment
- Demonstrated professionalism, reliability, and a strong work ethic
- Strong personal integrity and adherence to statistical and scientific ethical standards
- Commitment to accuracy, transparency, and responsible use of data
- Qualified candidates must be legally authorized in the United States. Cook does not intend to provide sponsorship for employment visa status’ for this employment position."
