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6 дней назад

Senior Principal Statistical Programmer (SAS)

152 000 - 190 000$
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 Principal Statistical Programmer (SAS): Designing, validating, and maintaining statistical programming deliverables for clinical trials from Phase I through regulatory submission with an accent on SAS, CDISC standards, and FDA/EMA compliance. Focus on generating SDTM, ADaM, and TLFs, supporting regulatory submissions, mentoring programmers, and bridging clinical programming with AI infrastructure.

Location: Remote - US

Salary: $152K–$190K annually

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven drug discovery and development platform.

What you will do

  • Lead the design, development, validation, and maintenance of SAS programs generating SDTM, ADaM, and tables, listings, and figures.
  • Ensure compliance with CDISC standards, FDA and EMA guidance, and internal SOPs.
  • Collaborate with biostatistics, data management, and clinical operations teams to define programming requirements and timelines.
  • Perform quality control and peer reviews while serving as a technical subject matter expert and mentoring junior programmers.
  • Support clinical study reports, regulatory submission packages, and responses to regulatory agencies.
  • Provide technical leadership for vendor oversight and outsourced programming activities.

Requirements

  • Bachelor’s or master’s degree in computer science, statistics, mathematics, life sciences, or a related field.
  • At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.
  • Strong proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph.
  • Strong experience with CDISC SDTM and ADaM, plus familiarity with define.xml and Pinnacle 21.
  • Experience supporting FDA and/or EMA regulatory submissions.
  • Must be based in the United States for this remote role.

Nice to have

  • Oncology experience.
  • Python familiarity.
  • Experience with cloud-based data systems or programming in a validated GxP environment.

Culture & Benefits

  • Inclusive environment focused on collaboration across diverse backgrounds and experiences.
  • Company-paid healthcare and flexible spending accounts.
  • Voluntary life insurance and 401(k) matching.
  • Uncapped vacation.
  • Access to a San Diego facility with an onsite gym and dining.

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