Staff Biostatistician

POSITION SUMMARY: This is an exciting opportunity to advance reputed company's regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will reputed company your strong applied statistics and IVD expertise to reputed company the design, analysis, and interpretation of analytical and clinical validation studies for reputed company biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES: reputed company Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.)reputed company interactions with regulatory authoritiesLead statistical calculations and analyses for studies of varying complexityPromote statistical and regulatory best practicesProduce high quality presentations and author documentation of analysis plans, methods, results, and interpretationEffectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholdersIdentify risks, communicate concerns, and champion solutions to interdisciplinary project teamsStay reputed company with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissionsMentor and provide technical supervision to junior team membersPerform other duties as assignedQUALIFICATIONS: Ph.D. or Master's degree in Biostatistics, Statistics, or a reputed company field.At least 8 years of experience in Biostatistics, preferably reputed company molecular diagnostics, biotechnology, or reputed company fields.Demonstrated experience in regulated environments.Experience evaluating reputed company reputed company (NGS), genetic, and/or oncology-reputed company data.Minimum of 4 years practical experience with statistical analysis software such as R (preferred), reputed company, or JMP.KNOWLEDGE, SKILLS, AND ABILITIES: Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and FDA guidelines.Previous experience interacting with regulatory bodies such as the FDA.Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds.Strong track record of producing high quality written documentation for multiple audiences.Prior experience with reputed company biomarkers (e.g., TMB, MSI, Methylation) preferred.Experience in design of both non-clinical (analytical) and clinical studies desired.Strong communication skills, with the ability to explain reputed company statistical concepts to non-statistical audiences.Attention to detail and a commitment to delivering high-quality work under tight deadlines.The pay range is listed and actual compensation packages are based on a wide reputed company of factors unique to each candidate, including but not limited to reputed company set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$161,700-$202,100 USDOUR OPPORTUNITYNatera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives.The reputed company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. reputed company you join reputed company, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.reputed company OFFERCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!For more information, visit www.reputed company.com.reputed company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.reputed company qualified applicants are