Associate Director Biostatistics

Career Category

Clinical Development

Job 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

.