Associate Director Biostatistics

About the role

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. The role combines hands-on technical leadership with managerial responsibility, overseeing statistical contributions to clinical trials, leading study teams and supporting regulatory and reimbursement submissions while mentoring and managing statisticians.

Key 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 other key trial documents.
• Ensure study design and analysis align with scientific rigor, regulatory requirements and Amgen policies.
• Collaborate cross-functionally with global teams on 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 and represent Biostatistics externally with regulators, investigators and data monitoring committees.
• Drive technology adoption, including AI capabilities, to streamline statisticians' work.

Required profile

• 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 with at least 8 years of post-graduate statistical experience in the same fields.
• Successful managerial experience of a group of statisticians and statistical programmers.
• Preferred: doctorate with at least 7 years of post-graduate experience, or master's with at least 10 years; prior experience growing a team of statisticians in Clinical Development.

Required skills

• Experience developing interactive or advanced visualizations of clinical trial data is a plus.
• Familiarity with R or Python is preferred.