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Senior Statistical Programmer Analyst - T
Science Technology
💰 Salary US$65–US$115/mo (US$780–US$1,380/yr)
📊 Market US$8,500–US$12,500/mo (US$102,000–US$150,000/yr)
About the Company
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant. No. 5 on the Greater Bay Area Manufacturers List, San Francisco Business Times, 2020 100 Fastest-Growing Companies, Fortune, 2019 Review our community guidelines for LinkedIn here: https://bit.ly/2Jmbw83. Medical Equipment Manufacturing Specialties: Neurointerventional devices, Stroke treatment, Vascular access, Thrombectomy systems, Interventional radiology, Medical device innovation
Responsibilities
- ● General Summary
- ● Under general supervision of a Statistics Project Manager or higher, prepares analysis programs to support the preparation and statistical analysis of clinical data. Works closely with other programmers, biostatisticians, and clinical data managers with a leading role in the collection, analysis, and reporting of clinical data for trials.
- ● Specific Duties and Responsibilities
- ● Following specifications, develops algorithms and writes programs to create datasets.
- ● Produces data listings, summary tables and graphs using analysis software.
- ● Independently checks data listings, summary tables and graphs.
- ● Imports and exports data.
- ● Assists data management group in performing data edit checks to facilitate data cleaning.
- ● Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
- ● Prepares clinical trial datasets and programs for regulatory submission.
- ● Following statistical analysis plan, writes specifications for analysis datasets.
- ● Interacts with the project statistician and other programmers participating on a project team.
- ● Manage the data warehouse used to manage libraries of clinical study data.
- ● Interact with regulatory affairs, quality assurance staff, and external clinical system vendors.
- ● Mentors less experienced statistical programmers.
- ● Act as the subject matter expert on CDISC and good statistical programming practices.
- ● Builds efficient SAS coding and macro libraries.
- ● Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- ● Adhere to the Company's Quality Management System (QMS) as well as domestic and global
- ● quality system regulations, standards, and procedures.
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