Job Description:
• Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.).
• Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying complexity.
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation.
• Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders.
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams.
• Mentor and provide technical supervision to junior team members.
• Perform other duties as assigned.
Requirements:
• Master’s degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience.
• Previous diagnostic experience.
• Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP.
• Experience designing and executing statistical analyses in a regulated environment.
Benefits:
• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for Natera employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.