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 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen