
1001 - 5000 employees
Founded 2004
đĽ Healthcare
đ Manufacturing
âď¸ Healthcare Insurance
Healthcare ⢠Manufacturing ⢠Healthcare Insurance
Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.
đĽ 4 minutes ago
đşđ¸ United States â Remote
đľ $65 - $115 / hour
â° Full Time
đ Senior
đĽ Software Engineer
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1001 - 5000 employees
Founded 2004
đĽ Healthcare
đ Manufacturing
âď¸ Healthcare Insurance
Healthcare ⢠Manufacturing ⢠Healthcare Insurance
Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.
⢠Prepare analysis programs supporting the preparation and statistical analysis of clinical data ⢠Develop algorithms and write programs to create datasets following specifications ⢠Produce and independently check data listings, summary tables, and graphs using analysis software ⢠Import and export data ⢠Assist data management with data edit checks and data cleaning ⢠Maintain understanding of CDISC guidance, implementation guides, and FDA electronic-submission guidance and regulations ⢠Keep current with industry trends in data mapping, data management, standards compliance, metadata management, and data warehousing ⢠Prepare clinical trial datasets and programs for regulatory submission ⢠Write analysis-dataset specifications following statistical analysis plans ⢠Interact with project statisticians and other programmers on project teams ⢠Manage the data warehouse used for clinical study data libraries ⢠Collaborate with regulatory affairs, quality assurance staff, and external clinical system vendors ⢠Mentor less experienced statistical programmers ⢠Serve as subject matter expert on CDISC and statistical programming practices ⢠Build SAS coding and macro libraries ⢠Conduct work consistent with GCP, ICH, 21 CFR Part 11, SOPs, training, and regulatory requirements ⢠Adhere to and help ensure departmental compliance with the Quality Management System and applicable regulations ⢠Perform other work-related duties as assigned
⢠Bachelor's degree in Statistics, Computer Science, or related field with 5+ years of statistical programming experience and 3+ years of clinical statistical programming experience within the medical device or related industry, or equivalent combination of education and experience ⢠Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT ⢠Knowledge of international regulations, requirements, and guidance associated with clinical data standards and clinical databases used for regulatory submission ⢠Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology ⢠Knowledge of clinical data management systems, such as Oracle InForm and/or RAVE ⢠Expertise using SAS for data import, manipulation, analysis, export, and graph generation ⢠Proficiency developing SAS macros to access, extract, modify, merge, and analyze clinical data ⢠Strong oral, written, and interpersonal communication skills ⢠High degree of accuracy and attention to detail ⢠Proficiency with MS Word, Excel, and other standard office tools ⢠SAS Certified Base and/or Advanced Programmer experience is preferred ⢠Experience with macro programming, SAS/SQL, metadata repositories, and regulatory submissions is a plus ⢠Ability to handle multiple tasks ⢠Approximately 10% travel to conferences and/or other Penumbra affiliated facilities
⢠Medical, dental, vision, life, AD&D, short-term disability, and long-term disability insurance ⢠401(k) with employer match ⢠Paid parental leave ⢠Eleven paid company holidays per year ⢠Minimum of fifteen days of accrued vacation per year, increasing with tenure ⢠Paid sick time in compliance with applicable law(s) ⢠Collaborative teamwork environment with constant learning ⢠Performance rewards ⢠Opportunity to contribute to therapies for devastating diseases
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