5 дней назад
Biostatistics Manager (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Biostatistics Manager (Biotechnology): Providing statistical expertise for clinical studies across the drug development lifecycle with an accent on study design, clinical trial methodology, and regulatory-quality analysis. Focus on developing statistical documents, delivering rigorous tables, figures, listings, and reports, and implementing AI technology to streamline statisticians' work.
Location: Taipei, Taiwan
Company
is a biotechnology company developing innovative human therapeutics and manufacturing capabilities to deliver medicines to patients worldwide.
What you will do
- Provide statistical input, review, and quality control for study design documents, protocols, and key design elements.
- Serve as the biostatistics lead on clinical study teams, supporting trial execution, risk assessments, data quality, and alignment with study objectives.
- Oversee statistical plans, randomization specifications, tables, figures, listings, submission data specifications, and related study documentation.
- Collaborate with cross-functional and external stakeholders to deliver analyses, clinical study reports, publications, and other communications.
- Maintain statistics sections of the trial master file, review supplier deliverables, and support policies, SOPs, process improvements, and operational efficiency.
- Contribute to signal detection thresholds and develop AI-enabled technology to streamline statisticians’ work.
Requirements
- MSc or PhD in Statistics, Biostatistics, or a related field.
- Approximately 3–5 years of relevant industry experience.
- Proven ability to apply statistical methods in clinical development.
- Knowledge of statistics in drug development, including innovative trial design and statistical policies and procedures.
- Ability to collaborate effectively with globally distributed, cross-cultural teams.
Nice to have
- Doctorate degree in Statistics or Biostatistics.
- Experience with machine learning, real-world data analytics, electronic health record data analysis, or clinical trial simulation.
- Experience across the drug development lifecycle.
Culture & Benefits
- Opportunities for learning and career progression across a global organization.
- Diverse and inclusive workplace where employees are encouraged to contribute ideas and take action.
- Total rewards package covering health, financial and wealth, work-life balance, and career benefits.
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