Associate Director Biostatistics
At a glance
Director-level Data Science role at Amgen. Taipei · full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Guide statistical decisions for clinical development, reimbursement and medical affairs teams
- Shape trial protocols, randomization plans, analysis plans and study reports, keeping work scientifically sound and compliant
- Lead statistical work across products from early development through post-marketing, including analyses and regulatory submissions
- Manage and mentor statisticians while overseeing outsourced statistical work and its compliance with standards
- Explore trial methods and AI-enabled tools, and represent Biostatistics with internal teams and external groups
What you bring
- A doctorate plus at least five years of relevant statistical work, or a master’s degree plus at least eight years
- A track record of managing statisticians and statistical programmers
- Training in statistics, biostatistics or a related subject with substantial statistical content
- Experience in pharmaceutical or medical research settings
Who this fits
This role suits a statistical leader who can combine hands-on clinical trial work with managing and mentoring a team. You’ll collaborate across countries and functions, and engage with regulators, investigators and data monitoring committees.
From the employer
Career Category
Clinical DevelopmentJob Description
What you will do
Amgen is expanding its global Biostatistics capabilities, with Amgen Taiwan playing a key role in integrated delivery and functional leadership. As Associate Director, Biostatistics, you will contribute statistical strategy, operational execution, and scientific leadership across Amgen’s clinical programs. You will oversee statistical contributions to clinical trials, lead study teams, and support regulatory and reimbursement submissions, while mentoring and managing statisticians. Throughcross-country and cross-functional collaborations, you will have the opportunity to contribute to innovative technologies that enhance scientific and/or operational efficiencies in drug development.
This role provides both hands-on technical leadership and managerial responsibility, ensuring quality, compliance, and innovation in biostatistical delivery aligned with Amgen’s global clinical development strategy.
Responsibilities:
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
- Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
- Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
- Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
- Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
- Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
- Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
- Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
- Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
- Execute biostatistical strategies across the product lifecycle, from early development through post-marketing.
- Provide consultancy and training to colleagues across R&D.
- Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance.
- Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees).
- Drive technology adoption leveraging AI capabilities to streamline statistician’s work
Basic Qualifications
- Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
- Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Successful managerial experience of a group of statisticians and statistical programmers.
Preferred Skills
- Doctorate in Statistics/Biostatistics (or related subject such as data science, engineering with high statistical content) with at least 7 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
- Master’s degree in Statistics/Biostatistics (or related subject such as data science, engineering with high statistical content) with at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Experience developing interactive or advanced visualizations to enhance interpretation of clinical trial data is a plus. Familiarity with R or Python is preferred.
- Prior experience in growing a successful team of statisticians within Clinical Development
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