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Senior Statistical Programmer Analyst - T

5 days, 15 hours ago
United States
Contract
Senior
Data Analyst
Software Development
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
1001-5000
Founded 2004
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Description

  • Develop algorithms and SAS programs to create clinical analysis datasets from specifications.
  • Produce and independently validate data listings, summary tables, graphs, and statistical outputs.
  • Import, export, preprocess, manipulate, and analyze clinical data.
  • Prepare clinical trial datasets, analysis-dataset specifications, and programs for regulatory submissions.
  • Support data cleaning by assisting with data edit checks.
  • Maintain and manage the clinical study data warehouse and programming libraries.
  • Partner with biostatisticians, clinical data management, regulatory affairs, quality assurance, and external system vendors.
  • Serve as a subject matter expert on CDISC and statistical programming practices; mentor junior programmers.
  • Ensure work complies with GCP, ICH, 21 CFR Part 11, internal SOPs, QMS, and global regulatory requirements.

Requirements

  • Bachelor's degree in Statistics, Computer Science, or a related field, or an equivalent combination of education and experience.
  • 5+ years of statistical programming experience, including 3+ years in clinical statistical programming within medical device, biotechnology, pharmaceutical, or CRO environments.
  • Proficiency with Base SAS, SAS/GRAPH, SAS/ODS, SAS/STAT, SAS/SQL, SAS/ACCESS, SAS data steps, PROCs, and macro programming.
  • Experience developing SAS macros to extract, modify, merge, and analyze clinical data.
  • Knowledge of CDISC standards, including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.
  • Knowledge of international clinical-data regulations and guidance for regulatory submissions.
  • Experience creating analysis outputs, including tables, listings, graphics, Kaplan-Meier plots, and statistical analyses.
  • Familiarity with clinical data management systems such as Oracle InForm and/or RAVE.
  • SAS Base and/or Advanced Programmer certification, metadata repository experience, and regulatory submission experience preferred.
  • Strong communication, multitasking, accuracy, attention to detail, and Microsoft Office skills; ability to travel approximately 10%.

Benefits

  • Hourly base pay range of $65.00–$115.00, depending on qualifications, skills, competencies, and location.
  • 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 annually.
  • At least 15 days of accrued vacation annually, increasing with tenure.
  • Paid sick time in accordance with applicable law.
  • Collaborative work environment with ongoing learning and performance recognition.

Interested in this position?

Apply directly on the company website

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