Senior Biostatistician — Medical Device R&D

BD

Montgomery (AL)

On-site

USD 110,000 - 176,000

Full time

6 days ago
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Job summary

BD in the United States seeks a Statistician/Biostatistician to support product development, clinical studies, and regulatory compliance in a medical device environment. You will design studies, develop statistical analysis plans, and run analyses in R or SAS, delivering clear technical reports and insights for cross-functional teams.

The role emphasizes collaboration, regulatory understanding, and strong communication of results to project teams, with opportunities to contribute to publications

Qualifications

  • Master's degree in Statistics, Biostatistics, or a related quantitative field (or equivalent combination of education and experience).
  • 3+ years of experience with a Master's degree, 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.
  • Experience managing multiple projects and priorities simultaneously in a fast-paced environment.
  • Experience with technical report writing and presentation of statistical findings.
  • Experience in stakeholder management.

Responsibilities

  • Partner with cross-functional teams to design, plan, analyze, and interpret studies that support product development and business decisions.
  • Develop and review study protocols, CRFs, and regulatory documentation.
  • Independently develop and maintain statistical analysis plans; seek consultation for complex cases.
  • Program, document, validate, and maintain statistical code in R and/or SAS for data management, analysis, visualization, reporting.
  • Apply appropriate statistical methodologies to address standard and complex analytical challenges.
  • Prepare clear, concise, and scientifically rigorous statistical reports for internal/external audiences.
  • Deliver high-quality statistical analyses that support project milestones across products and functions.
  • Stay current with emerging statistical methodologies and regulatory requirements.
  • Present statistical findings to stakeholders and contribute to publications and presentations.

Skills

Statistical analysis
Study design
Cross-functional collaboration
Data interpretation
Communication of results

Education

Master's degree in Statistics/Biostatistics or related field

Tools

R
SAS

Job description

BD in the United States seeks a Statistician/Biostatistician to support product development, clinical studies, and regulatory compliance in a medical device environment. You will design studies, develop statistical analysis plans, and run analyses in R or SAS, delivering clear technical reports and insights for cross-functional teams.

The role emphasizes collaboration, regulatory understanding, and strong communication of results to project teams, with opportunities to contribute to publications

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