Senior Statistical Programmer Analyst
$65 - $115/hr
Senior
Bachelor's
Remote in USA
Remote
Biology & BiotechQuantitative Biology & Biostatistics
Company Historically Provides H1B Sponsorship
About the job
Requirements
- A bachelor's degree in Statistics, Computer Science, or a related field, with 5+ years of statistical programming experience and 3+ years of clinical statistical programming experience in the medical device or a related industry, or an equivalent combination of education and experience.
- Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
- Ability to handle multiple tasks.
- Ability to identify ways to improve business performance and advocate for those improvements when necessary.
- 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 in using SAS for data import, including extracting raw data from a data warehouse with SAS/ACCESS and preprocessing it for statistical analysis; data manipulation using SAS data steps and procedures to modify, transform, generate, and process datasets with arrays, do loops, merges, PROC SQL, PROC SORT, and PROC TRANSPOSE; data analysis using PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TTEST, PROC GLM, PROC LOGISTIC, PROC LIFETEST, and PROC PHREG; data export using PROC REPORT, PROC SGPLOT, and SAS/ODS; and graphing methods including Kaplan-Meier plots, box plots, bar charts, waterfall plots, forest plots, shift plots, life tables, and prevalence plots.
- Proficiency in developing SAS macros to access, extract, modify, merge, and analyze clinical data.
- Strong oral, written, and interpersonal communication skills.
- High accuracy and attention to detail.
- Proficiency with Microsoft Word, Excel, and other standard office tools.
- Ability to comply with a general office environment and to use a computer for extended periods; the role also requires the ability to stand, walk, sit, and reach with hands and arms, and the specified vision abilities.
- Approximately 10% travel to conferences and/or other Penumbra-affiliated facilities.
Responsibilities
- Develop algorithms and write programs to create datasets according to specifications.
- Produce data listings, summary tables, and graphs using analysis software.
- Independently check data listings, summary tables, and graphs.
- Import and export data.
- Assist the data management group with data edit checks to facilitate data cleaning.
- Maintain an in-depth understanding of CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic data submissions; keep current with industry trends in data mapping, data management, standards compliance methodologies, metadata management, and data warehousing.
- Prepare clinical trial datasets and programs for regulatory submission.
- Write specifications for analysis datasets according to the statistical analysis plan.
- Interact with the project statistician and other programmers on project teams.
- Manage the data warehouse used to manage libraries of clinical study data.
- Interact with regulatory affairs and quality assurance staff, and external clinical system vendors.
- Mentor less experienced statistical programmers.
- Act as the subject matter expert on CDISC and good statistical programming practices.
- Build efficient SAS code and macro libraries.
- Conduct 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 and domestic and global quality system regulations, standards, and procedures.
- Ensure other department members follow the Quality Management System, regulations, standards, and procedures.
- Perform other work-related duties as assigned.
Desired Qualifications
- SAS Certified Base and/or Advanced Programmer experience is preferred.
- Experience with macro programming and SAS/SQL is a plus.
- Experience with a metadata repository in clinical data is a plus.
- Experience with regulatory submissions is a plus.
About the company
Penumbra develops and sells medical devices for neurovascular and peripheral vascular conditions. Its products assist doctors in treating stroke and other vascular diseases by delivering—through systems like the Penumbra System and Indigo System—catheters, coils, and evacuation devices that are placed inside blood vessels. The company differentiates itself with a broad, integrated portfolio and a global sales network across Europe and the Americas, emphasizing engineering and clinical performance. Its goal is to improve patient outcomes and sustain growth by investing in ongoing research and development to expand its capabilities.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Alameda, California
Founded
2004
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Simplify's Take
What believers are saying
- Q2 2026 revenue reached $390.0 million, up 14.9%, with 67.9% gross margin.
- September 9, 2026 Link launch expands Lightning Bolt workflows for resistant clot.
- Magnendo's $18 million round, led by Penumbra, extends its stroke robotics ecosystem.
What critics are saying
- June 3, 2026 RED 68 recall flags manufacturing defects and franchise reliability.
- Incuvate sued Penumbra on August 19, 2026 over THUNDERBOLT patents; injunction risk.
- Boston Scientific's acquisition still requires approvals; any 2026 slip derails employee retention and valuation.
What makes Penumbra Inc unique
- Penumbra's CAVT platform pairs computer control with thrombectomy; THUNDERBOLT cleared FDA in 2026.
- Broad neurovascular and peripheral portfolios sell into over 100 countries.
- Deep physician evidence engine adds leaders like Donald Frei and published stroke studies.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- 401(k) Retirement Plan
- 401(k) Company Match
- Paid Parental Leave
- Paid Vacation
- Paid Sick Leave
- Paid Holidays