Position Description:

Responsible for providing technical expertise as part of the Statistical Programming (SP) group to develop and maintain programs and process methodology to meet internal and external clients' needs related to medical device products. Plan the development of solutions to all statistical analysis programming needs to include complex studies like Premarket Approval (PMAs) studies. Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics, and listing summaries. Utilize Base SAS®, SAS/STAT, SAS Macro language, SAS/SQL, SAS/GRAPH, SAS/Access and SAS/ODS. Work on multiple environments PC/UNIX. Working in a regulated medical device or pharmaceutical business. Coordinates clinical trial analysis and Statistical Analysis Planning and Strategies. Prepares data for FDA regulatory submission including electronic submissions. Utilizes CDISC standards for facilitating electronic submissions to regulatory authorities to include the FDA. Leverages knowledge from being a SAS Certified Programmer. This position does not have any direct reports or management duties. Position is open to telecommuting from anywhere in the United States. Multiple positions available. #LI-DNI.

Basic Qualifications:

Requirements: Master's degree in Biotechnology, Computer Science, Information Technology, Biostatistics, Statistics, or a related field. Requires two (2) years as an IT Developer or Clinical IT Developer or related occupation. Must possess at least two (2) years as an IT Developer or Clinical IT Developer or related occupation, and two (2) years' post-Bachelor's experience with each of the following: Base SAS®; SAS/STAT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/Access and SAS ODS; PC/UNIX SAS Environments; Working in a regulated medical device or pharmaceutical business; Coordinating trial analysis and Statistical Analysis Planning and Strategies; Preparing data for FDA regulatory submission; CDISC SDTM and ADAM Standards. The following Certification is required: Must be a Certified BASE SAS Programmer.

The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432 and is open to telecommuting from anywhere in the United States.

Salary: $115,100 to $159,600 per year