Senior Clinical IT Developer
4 weeks ago
Medtronic is seeking a highly skilled Clinical IT Developer to join our team. As a key member of our Statistical Programming group, you will be responsible for developing and maintaining programs and process methodology to meet the needs of our internal and external clients related to medical device products.
Key Responsibilities:
• Plan the development of solutions to all statistical analysis programming needs, including 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 to develop and maintain programs and process methodology.
• Work on multiple environments, including PC and UNIX, and coordinate clinical trial analysis and Statistical Analysis Planning and Strategies.
• Prepare data for FDA regulatory submission, including electronic submissions, and utilize CDISC standards to facilitate electronic submissions to regulatory authorities.
Requirements:
• Master's degree in Biotechnology, Computer Science, Information Technology, Biostatistics, Statistics, or a related field.
• Two (2) years of experience as an IT Developer or Clinical IT Developer or related occupation.
• 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.
• Must be a Certified BASE SAS Programmer.
What We Offer:
• Competitive salary range: $115,100 to $159,600 per year.
• Opportunity to work with a leading medical device company and contribute to the development of innovative solutions.
• Collaborative and dynamic work environment with a team of experienced professionals.
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