Edwards Lifesciences

Principal Biostatistician

Edwards Lifesciences

full-time

Posted on:

Location Type: Remote

Location: Remote • California • 🇺🇸 United States

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Salary

💰 $129,000 - $182,000 per year

Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Statistical lead on one or more clinical trials
  • Lead the coordination of analyses for study report and other documents
  • Provide programming and validation support of these analyses
  • Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA)
  • Represent Biostatistics on project/study teams
  • Coordinate/communicate with management regarding project/study status
  • Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts
  • Compile technical documents for internal and external audits
  • Contribute to the improvement, standardization, and globalization of Biostatistics processes
  • Collaborate on developing case report forms and clinical database to ensure quality data collection
  • Lead the efforts of data analysis for data monitoring committee as needed

Requirements

  • Ph.D. or equivalent in Statistics, Biostatistics, or related field
  • 2 years’ experience
  • Training or publications in Bayesian methodology
  • Expertise in MS Office (Word, PowerPoint, Access, Excel)
  • Up-to-date on statistical and regulatory developments
  • Deep knowledge of clinical trial design, statistical modeling, and data analysis
  • Proficient in SAS; experience with R, S-Plus
  • Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices
  • Excellent problem-solving, analytical, and critical thinking skills
  • Proven leadership and ability to influence change
  • Skilled in training/coaching and facilitating organizational change
Benefits
  • Competitive salaries
  • Performance-based incentives
  • Wide variety of benefits programs to address the diverse individual needs of our employees and their families

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
statistical analysisBayesian methodologyclinical trial designstatistical modelingdata analysisSASRS-Plusprogrammingvalidation support
Soft skills
problem-solvinganalytical skillscritical thinkingleadershipinfluence changetrainingcoachingfacilitating organizational changecollaborationcommunication
Certifications
Ph.D. in StatisticsPh.D. in Biostatistics