Biostatistical Programming Senior Associate

Career Category
Business Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Biostatistical Programming Senior Associate in Taipei, Taiwan.

Live

What you will do

Amgen is expanding its global Statistical Programming capabilities, with Amgen Taiwan playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.

Key Responsibilities:

Analysis and reporting of clinical trial data using SAS and/or R

Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy

Creation and validation of complex tables, listings, and figures, both safety and efficacy

Prepare statistical programming specifications

Prepare statistical programming related documents for regulatory submissions

Maintain tracking and validation documentation

Collaborate with cross-functional team and create and/or validate complex programs for checking data quality

Interact and collaborate with study team members from other functions globally

Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP

Win

What we expect of you

Basic Qualifications:

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment.

Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data

Ability to effectively perform complex statistical programming and related tasks

Ability to provide quality output and deliverables in adherence with challenging timelines

Ability to work effectively on multiple tasks or projects across therapeutic areas

Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards

In depth knowledge of SAS/STAT packages

Familiar with data quality and compliance check tools

Excellent oral and written English communication skills

Preferred Skills:

MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects

Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming

Prior regulatory submission experience for drug approval

Thrive

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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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.

.