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.
Description
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: $102,000 - $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