5 дней назад
Biostatistical Programming Senior Associate (Biotechnology)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Biostatistical Programming Senior Associate (Biotechnology): Conducting statistical analyses and developing clinical-trial documentation, datasets, and outputs with an accent on SAPs, TFLs, SDTM/ADaM specifications, and CDISC-compliant quality control. Focus on analyzing clinical endpoints, collaborating with clinical study and programming teams, and supporting regulatory submissions and study reports.
Location: Taipei, Taiwan; onsite
Company
is a biotechnology company developing human therapeutics and supporting their delivery through global manufacturing and services.
What you will do
- Author and review Statistical Analysis Plans, TFL shells, randomization specifications, submission data specifications, and related study documentation.
- Conduct and document primary, secondary, exploratory, and dose-level analyses for clinical trials.
- Perform quality control of datasets and statistical outputs for accuracy, consistency, and CDISC compliance.
- Provide statistical input in Clinical Study Team meetings and collaborate with programming colleagues on study deliverables.
- Contribute to clinical publications, study reports, regulatory submissions, and Trial Master File maintenance.
- Review external supplier deliverables, monitor statistical methodology and regulatory guidance, and support audits.
Requirements
- Master’s degree in Statistics, Biostatistics, or a related subject with high statistical content and at least 2 years of post-graduate experience in pharmaceutical industry or medical research, or a doctoral degree with at least 1 year of experience.
- Competency in statistical programming with SAS or R.
- Experience applying statistical methods to the analysis and conduct of clinical trials.
- Ability to communicate clearly in English, both verbally and in writing.
- Strong understanding of drug development and statistical applications across the clinical lifecycle.
Nice to have
- Master’s degree with 4 or more years of post-graduate experience, or a doctorate with 2 or more years.
- Leadership of at least one study or project with minimal oversight.
- Experience authoring protocols and SAPs and reviewing CSRs.
- Familiarity with CDISC standards, including SDTM and ADaM.
- Experience using AI or automation tools to improve efficiency.
Culture & Benefits
- Opportunities for learning and career growth across a global organization.
- Diverse and inclusive workplace where employees can contribute ideas and take action.
- Total Rewards Plan covering health, financial, wealth, work-life balance, and career benefits.
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