Biostatistical Analyst

As a Biostatistical Analyst, you will apply statistical methods to support clinical research, new assay methods, and the design, validation, development, and delivery of in vitro diagnostic (IVD) devices. You will work closely with R&D, Regulatory, Quality Control, and Strategic Accounts, and you will help turn complex study data into clear findings that support regulatory submissions.

What you'll do

• Analyze and interpret analytical and clinical studies of IVD devices for submissions to regulatory bodies such as the FDA
• Support technical writing for documentation relevant to internal audits
• Write reports and technical documents that summarize project findings
• Prepare protocols, scientific abstracts, and peer-reviewed manuscripts, and help develop responses to statistical questions from regulatory agencies, Institutional Review Boards, and other health authorities
• Address statistical issues that arise in regulatory, quality, compliance, or other legal settings
• Provide statistical training for non-statistical colleagues in R&D and Quality Control
• Take part in department, division, and team meetings, and join client meetings, trade shows, scientific conferences, and industry events as needed
• Stay current on developments in statistics, the diagnostics industry, and regulatory guidance through literature review, workshops, and professional meetings

What you'll bring

• Master's degree in Biostatistics, Statistics, or a related field
• At least 2 years of experience directly related to designing, analyzing, and reporting
• Strong fluency with R, SAS, and/or Python
• Excellent written and verbal communication skills
• Strong ability to work with scientists and stakeholders across disciplines
• Ability to explain complex statistical concepts in terms a general audience can follow

Helpful knowledge and how you'll work

Technical knowledge that will help you succeed

• Proficiency with SAS/Base, SAS Macro, R, or Minitab
• Familiarity with general clinical laboratory operations and procedures
• Basic knowledge of FDA Design Control and Quality System Regulation (QSR) requirements
• Basic knowledge of FDA and EU submission processes and guidelines for IVD and In Vitro Diagnostic Regulation (IVDR) submissions
• Basic knowledge of Clinical and Laboratory Standards Institute (CLSI) guidelines, FDA guidance documents, and International Organization for Standardization (ISO) documents
• Ability to design experiments that test a clear, concise hypothesis