Biostatistical Programming Senior Associate
At a glance
Senior Data Science role at Amgen. Taipei · full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Analyze clinical-trial data and produce reports using SAS, R, or both
- Build and validate safety and efficacy datasets, including SDTM and ADaM formats
- Create and check tables, listings, figures, and programs that assess data quality
- Write programming specifications and prepare documentation for regulatory submissions
- Track validation work, collaborate with global study teams, and cover Study Lead Programmer tasks when needed
What you bring
- A quantitative or scientific degree, plus at least four years of statistical programming in clinical development
- Strong SAS/STAT skills and the ability to work with complex clinical-trial data
- Working knowledge of CDISC SDTM and familiarity with ADaM and Define standards
- Excellent written and spoken English, with the ability to deliver quality work across competing projects
Who this fits
This role suits someone comfortable with hands-on programming for clinical studies and regulatory submissions, working across therapeutic areas with globally dispersed, cross-cultural teams. The position is based in Taipei, Taiwan.
From the employer
Career Category
Business DevelopmentJob 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.
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