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4 дня назад

Senior Statistical Programmer (SAS)

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Statistical Programmer (SAS): Generating tables, listings, and graphs from clinical trial databases and preparing regulatory submission outputs with an accent on SAS programming, SDTM/ADaM standards, and clinical data compliance. Focus on developing pooled datasets, BIMO outputs, define.xml, Reviewer's Guides, and leading study or small programming project teams.

Location: Remote within the United States

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device industries with clinical trial data and regulatory submission services.

What you will do

  • Generate tables, listings, and graphs from clinical trial databases using SAS.
  • Develop programming deliverables in accordance with the System Development Life Cycle.
  • Prepare pooled datasets and regulatory submission outputs, including BIMO outputs, define.xml, Reviewer's Guides, and SDSP.
  • Write and support specifications for SDTM and ADaM standards.
  • Lead study teams or small statistical programming project teams.

Requirements

  • Legal authorization to work in the United States for any employer is required; visa sponsorship and work authorization transfers are not available.
  • Master's degree required for Statistics roles.
  • At least 5 years of experience in statistical programming or a similar field.
  • Advanced SAS programming skills, including SAS Base and SAS Macros.
  • Knowledge of SDTM, ADaM, E-Submission Standards, ICH, FDA, GCP, 21 CFR Part 11, and ISO requirements.
  • Strong scientific, problem-solving, organizational, and communication skills.

Nice to have

  • Hands-on experience with clinical trials and pharmaceutical development.
  • Familiarity with current ISO 9001 and ISO 27001 standards.
  • Understanding of CROs, scientific and clinical terminology, and the drug development process.

Culture & Benefits

  • Supportive, collaborative, and inclusive work environment.
  • Remote work arrangement within the United States.
  • Opportunity to contribute to clinical research across pharmaceutical, biotech, and medical device projects.

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