Senior Biostatistician - Regulated Medical Device Analytics

BD

Indiana

On-site

USD 110,000 - 176,000

Full time

6 days ago

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Job summary

BD is seeking a Statistician/Biostatistician to support product development, clinical studies, and business decisions within a regulated healthcare environment. This role partners with cross‑functional teams to design studies, develop analysis plans, analyze data, and communicate actionable insights using R and/or SAS.

The ideal candidate holds a Master’s or PhD in Statistics/Biostatistics and has experience in regulated healthcare or medical devices.

Qualifications

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

Responsibilities

Design, plan, analyze, and interpret studies and experiments to support product development and business decisions.
Develop and review study protocols, case report forms, and regulatory documentation.
Independently develop and maintain statistical analysis plans; seek consult for complex cases.
Program, document, validate, and maintain statistical code in R and/or SAS for data management and reporting.
Apply appropriate statistical methodologies to address standard and complex challenges.
Prepare clear, concise, scientifically rigorous statistical reports and documentation.
Deliver high-quality analyses and insights across products, platforms, and functions.
Stay current with emerging statistical methodologies and regulatory requirements.
Present findings to cross-functional stakeholders and contribute to publications and conferences.