Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina - long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life. Position Overview The Sr. Biostatistician/SAS Programmer will utilize statistical and programming expertise in analysis and reporting of clinical trial programs; submission and defense of regulatory filings and the generation of evidence to support product commercialization and reimbursement. Responsibilities include the development of Statistical Analysis Plans, including statistical methodology, definition of derived variables, data-handling rules, mockups and ultimately analysis of study data in support of business needs. This work is accomplished with limited supervision and requires a motivated, self-starter who can work independently. Essential Job Functions Participate in the design and execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management. Statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs, and response to regulatory questions. Support analysis for publications or podium presentations. Develop SAS macros, templates and utilities for data reporting and visualization. Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets. Proactively seek out and follow best practices in programming documentation. Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams. Regularly communicates study status to senior management and represents the organization to key customers. Other duties as assigned. Requirements B.S. degree in statistics, computer science, mathematics or related areas and 5+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master's degree in Biostatistics or Epidemiology and 3+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials Proficiency in SAS that includes the use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis required Experience with analysis of medical device trials for PMA or 510(k) preferred Excellent critical thinking skills Ability to work effectively on cross-functional teams Effective communication skills with all levels of management and organizations Operates both as a team and independently, with adaptability to changing requirements Market Range: $121,000 - $151,000 Exact compensation may vary based on skills, experience, and location. Benefits Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks: Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards EEO Employer Shockwave Medical Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origi /ancestry, age, disability, marital & veteran status.