Principal Biostatistician - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences   •  

Irvine, CA

Industry: Business Services


8 - 10 years

Posted 413 days ago

Essential Job Functions:

  • Prepares and maintains statistical analysis plan and coordinate the analyses for study report and other documents and provides programming and validation support of these analyses.
  • Represents Biostatistics on project/study teams and coordinate/communicates with management and other team members regarding project/study status and timeline update.
  • Provide statistical leadership in the preparation of PMA submissions and other regulatory documents as needed, and appropriately handle ad hoc data analysis requests and publication/presentation efforts related to the project team.
  • Reviews and approves the statistical section(s) of clinical study reports or other documents in support of a PMA or other regulatory submissions.
  • Mentors junior statisticians and work with management in resource allocation and budget/timeline development activities.
  • Lead the efforts of data analysis for data monitoring committee as needed.
  • Contributes to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs).



  • PhD in Statistics/Biostatistics and at least 5 years of clinical trialexperience within the medical device or pharmaceutical industries.
  • Masters in Statistics/Biostatistics and 8+ years of clinical trialexperience within the medical device, pharmaceutical, biotech industries.

Required Skills:

  • Up-to-date expertise/knowledge in advanced statistical methodologies related to clinical trial designs, statistical modeling and data analyses.
  • Must possess the ability to work on complex statistical problems, have proficient knowledge of SAS and familiarity with other statistical software packages. Bachelor's degree in related field required.
  • Must have the ability to clearly and effectively communicate with management, internal stakeholders and external parties, including regulatory authorities, using excellent written and oral communication and organizational skills.
  • Must have the ability to work both independently and as a part of a project team.
  • Must have exposure and familiarity with relevant ICH, FDA, and ISO guidelines and guidance documents and be able to search and review relevant medical literature.
  • Strong motivation to succeed and be able to mentor junior statisticians.