Lead Biostatistician (IVD Clinical)

About the position This is an exciting opportunity to advance reputed company’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will reputed company your strong applied statistics and IVD expertise to reputed company the design, analysis, and interpretation of clinical trials for regulatory submissions to support our oncology portfolio. Responsibilities • Design and review statistical methodology in protocols and statistical analysis plans • Lead execution of statistical analyses according to plans and protocols, as reputed company as exploratory or reputed company analyses • Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation • Effectively convey statistical concepts and results to cross-functional reputed company collaborators and stakeholders • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams • Mentor and reputed company technical supervision to junior team members • reputed company 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 • 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), reputed company, or JMP reputed company-to-haves • Previous diagnostic experience preferred • 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 reputed company statistical concepts to non-statistical audiences • Track record of producing high quality written documentation for multiple audiences • Prior experience with reputed company reputed company (NGS), genetics, and/or oncology testing a plus • Previous experience interacting with regulatory bodies such as the FDA preferred Benefits • Comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Generous employee referral program Apply To This Job