Job Description

Overview

We are seeking a Senior or Lead Biostatistician to provide strategic statistical leadership across a diverse portfolio of projects. This role will be a key partner to multidisciplinary teams spanning multiple therapeutic areas, supporting study design, analysis, and interpretation of data to advance Cook Medical's clinical, scientific, and product objectives.

The successful candidate will take ownership of the statistical components of assigned projects, collaborate closely with cross-functional stakeholders, and contribute to high-quality decision-making throughout the research lifecycle. In addition to project work, this role offers opportunities to advance statistical methodology, support internal training and capability building, and engage in external professional and scientific activities.

An ideal candidate builds strong scientific partnerships, communicates complex statistical concepts with clarity, and actively contributes to the organization's long-term analytic and methodological growth.

Responsibilities

• Provide expert statistical support for the concept development, design, analysis, and reporting of clinical, observational, and other scientific studies.
• Collaborate with scientists, clinicians, regulatory professionals, healthcare economists, and others to develop and implement effective analytic strategies that support decision-making and advance medical and scientific goals.

• Participate actively in project meetings and discussions to understand scientific, operational, and business needs.
• Offer computational and statistical guidance on complex analytic questions.
• Demonstrate strong programming skills, with experience in SAS and R.
• Represent Cook Medical in interactions with regulatory and professional organizations, contributing to scientific knowledge and the evolution of statistical and methodological standards.

• Stay current with emerging statistical methodologies, analytic techniques, and relevant scientific literature.

• Disseminate modern statistical methods and tools to colleagues through training, consultation, and collaboration.

• Acquire and maintain Cook Mastery Level of Artificial Intelligence competency, including the ability to assess feasibility and risk of AI use cases, design or coordinate workflow-level AI solutions, guide teams on responsible AI governance, mentor others, and contribute to organizational policies and ethical decision-making.
• Provide leadership by guiding project teams, influencing stakeholders, and supporting the development of other colleagues.

Qualifications

The following qualifications are required:

• MS minimum, in biostatistics, statistics, or a related quantitative discipline. PhD preferred.
• 5 years or more of relevant experience supporting clinical study design and analysis.
  • Candidates with fewer years of experience but exceptional methodological or research credentials will be considered.
• Demonstrated ability to lead, influence, collaborate, and provide mentorship to peers and junior colleagues.
• Excellent oral and written communication skills.
• 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.

The followng qualifications are preferred:

• Strong understanding of clinical study design: power and sample size calculations, Type I error control, statistical analysis planning, and interpretation of results, across a variety of study designs including RCTs, performance goals and real-world evidence.
• Experience with advanced inferential and predictive modeling methods (e.g., survival analysis, longitudinal data analysis, missing data, generalized linear models, causal inference, machine learning techniques, and related methods).
• Experience with real-world data sources such as U.S. CMS data and EMR data.
• Evidence of thought-leadership through presentations, publications, or contributions to professional societies.
• Ability to clearly communicate statistical concepts and results to scientific and business partners.
• Demonstrated leadership capabilities, including collaboration, coaching, and guiding project work to achieve meaningful impact.

Job Tags

Full time

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