Senior Biostatistician for Regulated Medical Devices

BD; Kansas; On-site; USD 90,000 - 130,000; Full time

Job summary

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decision-making within a regulated healthcare or medical device environment. The ideal candidate will design studies, develop statistical analysis plans, analyze complex data, and communicate actionable insights using R and/or SAS.

This role requires collaboration across functions and strong communication skills.

Qualifications

• Master's degree in Statistics, Biostatistics, or related field.
• 3+ years of experience 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.

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 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.

Skills

Statistical analysis

Cross-functional collaboration

Study design

Data interpretation

Communication

Education

Master's degree in Statistics, Biostatistics, or related field

PhD in Statistics, Biostatistics, or related quantitative discipline

Tools

R

SAS

Job description

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decision-making within a regulated healthcare or medical device environment. The ideal candidate will design studies, develop statistical analysis plans, analyze complex data, and communicate actionable insights using R and/or SAS.

This role requires collaboration across functions and strong communication skills.