Senior Biostatistician for Medical Device R&D & Regulation

BD; Indianapolis (IN); Sur place; USD 110 000 - 176 000; Plein temps

Avantages offerts par ce poste

Health & Well-being benefits

401(k) plan

Paid time off

Résumé du poste

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare environment. The role collaborates with cross-functional teams to design studies, create analysis plans, and communicate insights using R or SAS.

Master’s or PhD in Statistics/Biostatistics with 3+ years in regulated settings is preferred. The candidate will develop statistical code, ensure quality and regulatory compliance, and contribute to reports and

Qualifications

• Master's or PhD in Statistics, Biostatistics, or related field
• 3+ years in regulated healthcare, life sciences, or medical device environments
• Experience applying statistical methods to product development or clinical research
• Proficiency with R and/or SAS for analyses and reporting
• Experience solving statistical challenges and guiding cross-functional teams
• Experience leading/staffing across multiple projects in fast-paced settings
• Strong communication and ability to translate findings into business recommendations
• Experience with reproducible research practices and regulatory considerations

Responsabilités

• Design, plan, analyze, and interpret studies supporting product development and decisions
• Develop and review study protocols and case report forms
• Develop and maintain statistical analysis plans and code in R/SAS
• Document and validate statistical analyses for reports and communications
• Deliver high-quality statistical analyses across multiple products and functions
• Present findings to cross-functional stakeholders and contribute to publications

Connaissances

Statistical analysis

R

SAS

Study design

Communication

Cross-functional collaboration

Regulatory knowledge

Formation

Master's degree in Statistics/Biostatistics

PhD (preferred)

Outils

R

SAS

Description du poste

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decisions in a regulated healthcare environment. The role collaborates with cross-functional teams to design studies, create analysis plans, and communicate insights using R or SAS.

Master’s or PhD in Statistics/Biostatistics with 3+ years in regulated settings is preferred. The candidate will develop statistical code, ensure quality and regulatory compliance, and contribute to reports and