Senior Biostatistician — Regulated Medical Device Studies

BD; Sacramento (CA); On-site; USD 110,000 - 176,000; Full time

Job summary

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare environment. You will design studies, develop SAPs, analyze complex data in R or SAS, and communicate actionable insights across cross-functional teams.

The role requires a Master’s degree in Statistics/Biostatistics (PhD preferred), 3+ years in regulated settings, and robust experience with R or SAS.

Qualifications

• Master's degree in Statistics, Biostatistics, or 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 analyses using R and/or SAS.
• Experience independently solving statistical and analytical challenges.
• Experience leading cross-functional teams without direct authority.
• Experience managing multiple projects in a fast-paced environment.
• Experience with technical report writing and presenting statistical findings.

Responsibilities

• Partner with Medical Affairs and cross-functional teams to design, plan, analyze, and interpret studies and experiments supporting product development and business decisions.
• Contribute to study protocols, case report forms, and other clinical and regulatory documentation.
• Independently develop and maintain statistical analysis plans and seek consultation for complex situations.
• 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 for internal and external audiences.
• Deliver high-quality analyses and insights supporting milestones across products and functions.
• Stay current with emerging methodologies and regulatory requirements.
• Present findings to stakeholders and contribute to publications and external communications as appropriate.

Skills

Statistical analysis

Cross-functional collaboration

Regulatory awareness

Data interpretation

Education

Master's degree in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

R

SAS

Job description

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare environment. You will design studies, develop SAPs, analyze complex data in R or SAS, and communicate actionable insights across cross-functional teams.

The role requires a Master’s degree in Statistics/Biostatistics (PhD preferred), 3+ years in regulated settings, and robust experience with R or SAS.