обновлено 9 часов назад
Biostatistical Programming Manager (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →