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10 дней назад

Senior/Principal Statistical Programmer (Clinical Statistical Programming)

Формат работы
remote (только United_kingdom)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK
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 (Clinical Statistical Programming): Leading statistical programming across clinical trials and supporting regulatory submissions with an accent on SAS, CDISC standards, SDTM/ADaM datasets, and TLF reporting. Focus on validating complex programming deliverables, overseeing outsourced activities, and providing technical guidance across Oncology, Rare Disease, or Neuroscience studies.

Location: Remote in the United Kingdom

Company

hirify.global is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

  • Lead statistical programming activities across multiple clinical studies and compounds from study start-up through database lock, reporting, and regulatory submission.
  • Develop, review, and validate tables, listings, figures, SDTM and ADaM datasets, Define-XML, and related documentation.
  • Provide technical oversight for outsourced programming activities and ensure delivery quality, timelines, and compliance.
  • Collaborate with statisticians, clinical teams, data management, and other stakeholders to translate complex study designs and endpoints into programming solutions.
  • Maintain programming standards, SOPs, work instructions, and inspection-ready documentation.
  • Mentor statistical programmers and act as a subject matter expert for technical decisions and continuous improvement.

Requirements

  • English required for communication and collaboration.
  • 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
  • Strong SAS programming expertise, including development, quality control, validation, and documentation.
  • Strong knowledge of CDISC standards and hands-on experience with SDTM and ADaM specification, development, and programming.
  • Experience with TFL programming, clinical trial reporting, regulatory submissions, and complex clinical trial data.
  • Bachelor’s or MSc degree in Statistics, Mathematics, or another scientific discipline.

Nice to have

  • Experience in Oncology, Rare Disease, or Neuroscience.
  • Experience with R or other statistical programming packages.
  • Experience with NDA or sNDA submissions.
  • French language skills.

Culture & Benefits

  • Work directly for a single sponsor while receiving the career opportunities and security of a global CRO.
  • Work remotely from the United Kingdom.
  • Access to continuous training and development focused on technical competence and client processes.
  • Collaborate within a diverse organization of more than 4,000 professionals across over 20 countries.
  • Opportunities are expected to become available throughout 2027 based on client demand and business growth.

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