Biostatistical Senior Associate

Biostatistical Senior Associate

Amgen is expanding its global Biostatistics capabilities, with Amgen Taiwan playing a key role in integrated delivery and functional leadership. As a Biostatistics Senior Associate, you will provide hands-on statistical expertise to clinical studies across the drug development lifecycle. You will author and review statistical documents, perform data analyses, and collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and timely delivery of study outputs.

This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork.

Responsibilities

• Author and provide statistical contributions to Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, randomization specifications, submission data file specifications (SDTM/ADaM), and other key study-related documentation.

• Conduct and document statistical analyses for clinical trials, including primary and secondary endpoint analyses, exploratory analyses, and dose-level review support.

• Perform and document quality control of datasets and outputs to ensure accuracy, consistency, and compliance with CDISC standards.

• Participate in Clinical Study Team meetings to provide statistical input and represent Biostatistics.

• Collaborate with programming colleagues to ensure timely delivery of study outputs.

• Contribute to clinical publications, study reports, and regulatory submissions.

• Support the review of deliverables from external suppliers for quality.

• Stay abreast of new methodologies, tools, and regulatory guidelines in statistical practice.

• Ensure that statistical sections of the Trial Master File are maintained and up to date.

• Adhere to Amgen’s policies, SOPs, and relevant controlled documents, and support audits as needed.

• What we expect of you

Basic Qualifications:

• Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with 2 years post-graduate experience as a statistician in the pharmaceutical industry or medical research, OR
• Doctoral degree in Statistics/Biostatistics (or related subject with high statistical content) with 1 year post-graduate experience.
• Competency in statistical programming (SAS or R).
• Experience applying statistical methods in the analysis and conduct of clinical trials.
• Ability to clearly communicate in English, both written and oral.

Preferred Skills:

• Master’s degree with 4+ years post-graduate experience, or Doctorate with 2+ years.

• Prior leadership of at least 1 study/project with minimal oversight.

• Experience authoring protocols, SAPs, and reviewing CSRs.

• Familiarity with CDISC standards (SDTM, ADaM).

• Experience with AI/automation tools to drive efficiency.

• Strong understanding of drug development and statistical applications across the clinical lifecycle.

• What you can expect of us

• As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

• Equal Opportunity Statement

• Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

• We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

• Location: Business Development, Taipei, Taiwan, Taiwan