Senior Statistical Programmer Analyst
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Job Description
Senior Statistical Programmer developing SAS programs and datasets for clinical trials. Supporting regulatory submissions and data standards at Penumbra, an innovative healthcare company.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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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