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Senior Statistical Programmer Analyst - T

7 hours, 20 minutes ago
United States
Full-time
Senior
Data Scientist
Software Development
GCP
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004
View All Jobs 12

Description

  • Develop algorithms and SAS programs to create clinical datasets.
  • Produce and independently validate data listings, summary tables, graphs, and statistical analyses.
  • Import, export, preprocess, manipulate, and analyze clinical data.
  • Support data management with data edit checks and data cleaning.
  • Prepare clinical trial datasets and programs for regulatory submission.
  • Write analysis dataset specifications based on statistical analysis plans.
  • Manage the clinical data warehouse and maintain SAS coding and macro libraries.
  • Collaborate with statisticians, programmers, data managers, regulatory affairs, quality assurance, and external vendors.
  • Mentor statistical programmers and serve as a subject matter expert on CDISC and statistical programming practices.
  • Ensure compliance with GCP, ICH, 21 CFR Part 11, QMS requirements, SOPs, and applicable regulations.

Requirements

  • Bachelor’s degree in Statistics, Computer Science, or a related field, plus 5+ years of statistical programming experience and 3+ years of clinical statistical programming experience in medical device, biotechnology, pharmaceutical, or CRO settings; equivalent combinations may be considered.
  • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
  • Proficiency in SAS data manipulation, statistical procedures, reporting, visualization, SAS/SQL, and macro programming.
  • Knowledge of CDISC standards and related terminology, including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.
  • Knowledge of international clinical data regulations and requirements for regulatory submissions.
  • Experience with clinical data management systems such as Oracle InForm or RAVE.
  • SAS Base or Advanced Programmer certification experience preferred.
  • Experience with metadata repositories and regulatory submissions preferred.
  • Strong communication, multitasking, accuracy, attention to detail, and business improvement skills.
  • Proficiency with Microsoft Word, Excel, and standard office tools; approximately 10% travel required.

Benefits

  • Hourly base pay range of $65.00–$115.00.
  • Medical, dental, vision, life, AD&D, and short- and long-term disability insurance.
  • 401(k) plan with employer match.
  • Paid parental leave, 11 paid company holidays, at least 15 accrued vacation days increasing with tenure, and paid sick time.
  • Collaborative environment focused on continuous learning and performance recognition.

Interested in this position?

Apply directly on the company website

Apply Now

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