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Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The role of Manager, Biostatistics, provides statistical and programming leadership for Clinical and Medical Affairs programs. The Manager works collaboratively in partnership with Clinical and Regulatory Affairs to advance Shockwave Medical products. The position works across the entire clinical life cycle including study design, data collection, analysis and reporting of scientific results with minimal supervision. The Manager interacts with external statistical experts, regulatory and global health authorities and oversees the work of contract research organization (CRO) Biostatistics vendors. The Manager leads an internal group of SAS programmers and statisticians to ensure business goals are met. Essential Job Functions Lead or assign the statistical support for clinical programs including clinical strategy, project development and regulatory submission strategy. Lead statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs, and response to regulatory questions. Oversee the development of SAS macros, templates and utilities for data reporting and visualization. Oversee the development and validation of 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. Partner within Clinical Affairs to streamline metrics related to clinical study execution and refine clinical data review processes to ensure oversight of clinical studies. Ensure all regulatory requirements for work processes are met. Represent Biostatistics in regulatory discussions and study audits. Partner with Medical Affairs on data presentation strategy including scientific presentations and publications. Ensure appropriate interpretation of statistical results, and that study data are complete and accurate. Ensure consistency in clinical study reports and publications. Recruit, train and mentor Biostatistics resources, and ensure expertise in innovative statistical methods. Cross-functional training of statistical methodology within Shockwave Medical. Manage timelines and internal/external resources to deliver on business needs. Other duties as assigned. Requirements B.S. degree in computer science, statistics, mathematics or related areas and 10+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master's degree in Biostatistics or Epidemiology and 8+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry 2+ years of people management or relevant experience. Ability to travel 10% domestically and internationally. Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. Proficiency in SAS and SAS macros 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. Excellent critical thinking skills. Ability to work effectively on cross-functional teams. Effective written, verbal and presentation skills with all levels of management and organizations. Can operate within a team and independently, with adaptability to changing requirements. Market Range: $129,000-$191,000 Exact compensation may vary based on skills, experience, and location. Benefits Sh ckwave 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 origin/ancestry, age, disability, marital & veteran status.