Manager of Programming and Statistics

About the RoleAs Manager of the statistical team, you will lead and support all statistical and programmingactivities. This role will work with Scientific and Medical Affairs management, responsible foroversight of the design, validation, analysis and interpretation of clinical data from multiple registriesin support of product development and business objectives. The position is based out of ourWaltham office in the greater Boston area. Hybrid work environment, at least 3 days in-officeexpected.Position ResponsibilitiesLead statistical analysis and programming support within multiple studies to ensure timely and high-quality deliverables in assigned projects and areas.Manage individuals, resources, timelines and priorities for statistical projects.Use advanced statistical methods to validate and analyze data.Write efficient code for processing data utilizing tools such as EXCEL and R.Create processes for validating quality and accuracy of data.Perform statistical programming and data analysis, as well as database cleaning, verification and validation, and quality review of statistical analyses.Work with medical affairs staff and clinical investigators to determine appropriate study and protocol design.Act as a technical resource to provide advice on complex programming tasks, standards, and processes.Responsible for statistical analysis plans (SAP) and developmentvalidation of tableslistingsfigures for statistical reports.Support statistical methods and results sections for presentations, reports, regulatory documentsfilings and peer-reviewed manuscripts.Collaborate on development of case report forms and clinical databases to ensure quality data collectionMay be involved in analyses of "˜big data' for market assessments, as well as from public sources (such as UNOS).Organized, self-starter; problem solving and innovative skills with an ability to work in a fast-paced environment with a "roll up your sleeves" attitude .ExperienceAt least 5-10 years of experience in a biomedical life science or medical device company, programming using R statistical software, including experience managing a prehensive knowledge of statistical methodsPrior healthcare or medical device industry experienceProficiency in R programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as SAS, Python etc. is a plus.Prior experience working with research andor healthcare data.EducationBachelor's degree in biostatistics, statistics, epidemiology or similar area of study, required.Master's degree or higher in biostatistics or relevant area of study preferred.Proficient in Microsoft Office Suite.Transplant surgery medical knowledge is a plus.Experience or knowledge of FDA regulations or submissions is a plus.

Created: 2024-11-11