Senior Statistician

Job Description Summary

We are seeking a Statistician/Biostatistician to support product development, clinical studies, and business decision-making within a regulated healthcare or medical device environment. This role partners closely with cross-functional teams to design studies, develop statistical analysis plans, analyze complex data sets, and communicate actionable insights.

The successful Statistician will apply advanced statistical methodologies, program and validate analyses in R or SAS, prepare technical reports, and help ensure projects meet quality, regulatory, and business objectives.

Key Responsibilities

• Partner with Medical Affairs and cross-functional project teams to design, plan, analyze, and interpret studies and experiments that support product development and business decision-making.
• Contribute to the development and review of study protocols, case report forms, and other clinical and regulatory documentation.
• Independently develop and maintain statistical analysis plans, seeking consultation for complex or non-routine situations as needed.
• Program, document, validate, and maintain statistical code in R and/or SAS for data management, analysis, visualization, and reporting.
• Apply appropriate statistical methodologies to address standard and complex analytical challenges.
• Prepare clear, concise, and scientifically rigorous statistical reports and technical documentation for internal and external audiences.
• Deliver high-quality statistical analyses and insights that support project milestones across multiple products, platforms, and business functions.
• Stay current with emerging statistical methodologies, industry best practices, and evolving regulatory requirements.
• Present statistical findings to cross-functional stakeholders and contribute to scientific publications, conference presentations, and external communications as appropriate.

Minimum Required

• Master's degree in Statistics, Biostatistics, or a related quantitative field (or equivalent combination of education and experience).
• 3+ years of experience with a Master's degree, in regulated healthcare, life sciences, or medical device environment.
• Demonstrated experience applying statistical methods to product development, clinical research, and/or clinical trials.
• Proficiency in programming, documenting, and validating statistical analyses using R and/or SAS.
• Experience independently solving statistical and analytical challenges.
• Experience leading and influencing cross-functional teams without direct authority.
• Experience managing multiple projects and priorities simultaneously in a fast-paced environment.
• Experience with technical report writing and presentation of statistical findings.
• Experience in stakeholder management.

Preferred Experience and Skills

• PhD in Statistics, Biostatistics, or related quantitative discipline.
• 1+ years of professional experience with a PhD.
• Experience applying statistical methodologies in manufacturing, quality, regulatory, process improvement, or operational excellence initiatives.
• Knowledge of and experience working in a reproducible research environment.
• Working knowledge of applicable healthcare, clinical, and medical device regulations, with the ability to independently apply regulatory requirements.
• Experience supporting submissions, regulatory interactions, or compliance-related statistical activities.
• Publication or presentation experience at scientific conferences, industry forums, or peer-reviewed journals.
• Prior experience working across multiple product lines, business units, or global project teams.
• Demonstrated ability to drive continuous improvement through data-driven decision making and statistical innovation.