Senior Associate Biostatistical Programming

Career Category

Job Description

• Senior Associate Biostatistical Programming (Taipei Taiwan)

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds 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 Senior Associate Biostatistical Programming.

Live

What you will do

Amgen focuses on areas of high unmet medical need leveraging its expertise to deliver innovative solutions that improve health outcomes and lives. Since 1980 Amgen has become one of the worlds leading biotechnology companies reaching millions of patients globally and developing a robust pipeline of novel medicines.

Observational research plays a critical role in drug development and commercialization as regulators and payers increasingly rely on real-world evidence (RWE) to guide decision-making. The Center for Observational Research (CfOR) at Amgen generates and applies RWE across the drug development lifecycle to further understand the nature of disease (frequency distribution clinical course) and the safety and effectiveness of medicines.

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Taiwan. This role supports generating RWE through hands-on programming data management and generating reports based upon real-world data of health care. The programmer will partner with epidemiologists and cross-functional teams to clarify requirements resolve issues and deliver high-quality outputs.

The ideal candidate holds a bachelors degree and has at least four years of relevant experience in statistical programming including postgraduate research experience. Proficiency in SQL SAS and R programming is required. Strong scientific technical and communication skills; problem-solving; and ability to work effectively within a global team are essential.

Responsibilities:

• Develop test validate and execute programming code and macros that generate analysis datasets and tables listings and figures to support decision making in drug development
• Lead and develop technical programming and process improvement initiatives within CfOR
• Represent the programming team and collaborate with peers in clinical and epidemiology functions
• Manage programming activities and provide technical solutions to programming issues
• Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
• Write and review programming plans and dataset specifications
• Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
• Participate in the development of departmental policies and controlled documents
• Participate in the recruitment of programming staff
• Actively participate in external professional organizations conferences and meetings
• Contribute to the continuous improvement of programming processes

Win

What we expect of you

Qualifications

• Masters degree in Computer Science Statistics Mathematics Life Sciences Business Analyticsor related field OR
• Bachelors degree and 2 years of directly related experience OR
• Associates degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience
• At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting including postgraduate research experience
• Experience in SQL and statistical programming using SAS and R
• Track record establishing analysis standards QC/QA processes and controlled change management.
• Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
• Foundational understanding of medical statistics (e.g. study design hypothesis testing confidence intervals).
• Real-world evidence (RWE) generation in pharmaceutical or related research industries or statistical programming for clinical trials
• Strong individual contributor proficient in developing analysis datasets identifying data anomalies and ensuring program accuracy
• Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC
• Experience with Git-based version control and maintaining analysis documentation.
• Ability to produce validated traceable and reproducible analysis outputs under SOPs and quality systems.

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

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

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.

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.