Senior Biostatistician — Regulated MedTech & Clinical Studies

BD; Lansing (MI); Sur place; USD 110 000 - 176 000; Plein temps

Résumé du poste

BD seeks a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare or medical device setting. You will design studies, develop SAPs, analyze complex data in R/SAS, and prepare technical reports for quality, regulatory, and business objectives.

The role requires a Master's in Statistics/Biostatistics with 3+ years in regulated environments, proficiency in R/SAS, and experience guiding cross-functional teams.

Qualifications

• Master's degree in Statistics, Biostatistics, or a related quantitative field.
• 3+ years of experience in regulated healthcare, life sciences, or medical device environment.
• 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.

Responsabilités

• Design, plan, analyze, and interpret studies and experiments that support product development and business decisions.
• Develop and review study protocols, CRFs, and other regulatory documentation.
• Develop and maintain statistical analysis plans; consult for complex cases.
• Program, document, validate, and maintain statistical code in R and SAS for data management and reporting.
• Apply statistical methods to address standard and complex analytical challenges.
• Prepare clear statistical reports and technical documentation for internal and external audiences.
• Deliver high-quality analyses and insights supporting milestones across products and functions.
• Stay current with emerging methodologies and evolving regulatory requirements.
• Present findings to stakeholders and contribute to publications and conferences.

Formation

Master's degree in Statistics/Biostatistics

PhD in Statistics/Biostatistics (preferred)

Outils

R

SAS

Description du poste

BD seeks a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare or medical device setting. You will design studies, develop SAPs, analyze complex data in R/SAS, and prepare technical reports for quality, regulatory, and business objectives.

The role requires a Master's in Statistics/Biostatistics with 3+ years in regulated environments, proficiency in R/SAS, and experience guiding cross-functional teams.