Lead Biostatistician (IVD Clinical)

Primary Responsibilities

• Design and review statistical methodology in protocols and statistical analysis plans
• Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses
• 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

Qualifications

• 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
• At least 3 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions
• Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP
• Previous diagnostic experience preferred

Knowledge, Skills, and Abilities

• Expert knowledge of probability theory and statistics including the ability to evaluate and produce novel methods and applications
• Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences
• Track record of producing high quality written documentation for multiple audiences