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Biostatistical Programming Manager (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
c1
Страна
Taiwan
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
Biostatistical Programming Manager (Biotech) (Clinical Trials/Statistical Programming): Leading end-to-end statistical programming for clinical studies and regulatory deliverables with an accent on programming strategy, CDISC standards, and delivery quality. Focus on managing study programmers, performing hands-on SAS/R programming, coordinating cross-functional teams, and supporting complex regulatory submissions.

Location: Taipei, Taiwan

Company

hirify.global is a biotechnology company developing human therapeutics and supporting their delivery through global manufacturing and services.

What you will do

  • Lead one or more clinical studies end to end as Study Lead Programmer.
  • Set programming strategies and manage timelines, quality, compliance, and deliverables.
  • Define and maintain programming specifications, including SDTM and ADaM specifications.
  • Lead statistical programming activities for integrated analyses and regulatory submissions.
  • Manage programmer assignments, data issue resolution, technical environments, and lookup tables.
  • Provide technical leadership, training, and guidance to statistical programmers and cross-functional study teams.

Requirements

  • Bachelor’s degree or higher in biostatistics, statistics, mathematics, computer science, or a related quantitative or scientific field.
  • At least 5 years of statistical programming experience in a clinical development environment.
  • Thorough understanding of clinical trial processes from data collection through analysis reporting.
  • In-depth knowledge of CDISC SDTM, ADaM, and Define standards.
  • Advanced analysis and reporting skills in SAS and/or R, including relevant statistical packages.
  • Excellent oral and written English communication skills and the ability to work with globally dispersed, cross-cultural teams.

Nice to have

  • Master’s degree or higher in statistics, biostatistics, mathematics, or a related field.
  • Experience with R, Python, open-source programming tools, automation platforms, or emerging statistical programming technologies.
  • Prior regulatory submission experience for drug approval.

Culture & Benefits

  • Opportunities for professional development and internal career mobility.
  • Diverse and inclusive workplace where employees can contribute ideas and take action.
  • Total rewards covering health, financial and wealth, work-life balance, and career benefits.

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