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Senior Statistical Programmer

2 hours, 53 minutes ago
United States
Full-time
Senior
Data Scientist
Data Science and Analytics
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 28

Description

  • Develop algorithms and write programs to create clinical datasets based on specifications.
  • Produce data listings, summary tables, and graphs using analysis software.
  • Independently check data listings, summary tables, and graphs for accuracy and consistency.
  • Import and export data and support data preprocessing for statistical analysis.
  • Assist the data management team with data edit checks to support data cleaning.
  • Prepare clinical trial datasets and programs for regulatory submission.
  • Write specifications for analysis datasets in accordance with the statistical analysis plan.
  • Coordinate statistical programming activities across multiple clinical projects and collaborate with project statisticians and other programmers.
  • Manage the data warehouse used to maintain libraries of clinical study data.
  • Interact with regulatory affairs, quality assurance staff, and external clinical system vendors.
  • Mentor less experienced statistical programmers and serve as a subject matter expert on CDISC and statistical programming best practices.
  • Build efficient SAS coding and macro libraries.
  • Adhere to GCP, ICH, 21 CFR Part 11, internal SOPs, the Quality Management System, and applicable security, privacy, and compliance requirements.

Requirements

  • Bachelor’s degree in statistics, computer science, or a similar quantitative field, or an equivalent combination of education and applicable experience.
  • 5+ years of statistical programming experience.
  • 3+ years of clinical statistical programming experience in medical device, biotechnology, pharmaceutical, or CRO settings.
  • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
  • SAS Certified Base and/or Advanced Programmer experience is preferred.
  • Experience with macro programming and SAS/SQL is a plus.
  • Knowledge of international regulations and guidance for clinical data standards and regulatory submission.
  • Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.
  • Experience with clinical data management systems such as Oracle InForm and/or RAVE.
  • Strong communication skills, attention to detail, and the ability to manage multiple tasks.
  • Expertise using SAS for data import, data manipulation, data analysis, data export, and graph generation.
  • Experience with metadata repositories and regulatory submissions is a plus.

Benefits

  • Annual base salary range of $140,000 to $191,000.
  • Competitive compensation package with a benefits and equity program, when applicable.
  • Medical, dental, vision, life, AD&D, and short- and long-term disability insurance.
  • 401(k) with employer match.
  • Paid parental leave.
  • Eleven paid company holidays per year.
  • Minimum of 15 days of accrued vacation per year, increasing with tenure.
  • Paid sick time in compliance with applicable law.

Interested in this position?

Apply directly on the company website

Apply Now

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