Senior Associate Biostatistical Programming
Amgen
Senior Associate Biostatistical Programming
Job Description
Career CategoryResearchJob DescriptionSenior Associate Biostatistical Programming(Taipei, Taiwan)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 Senior Associate Biostatistical Programming.LiveWhat you will doAmgen 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 world’s 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 bachelor’s 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 developmentLead and develop technical programming and process improvement initiatives within CfORRepresent the programming team and collaborate with peers in clinical and epidemiology functionsManage programming activities and provide technical solutions to programming issuesEnsure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standardsWrite and review programming plans and dataset specificationsReview 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 documentsParticipate in the recruitment of programming staffActively participate in external professional organizations, conferences, and meetingsContribute to the continuous improvement of programming processesWinWhat we expect of youQualificationMaster’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics,or related field ORBachelor’s degree and 2 years of directly related experience ORAssociate’s degree and/or 4 years of directly related experience ORHigh school diploma / GED and 6 years of directly related experienceAt least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experienceExperience in SQL, and statistical programming using SAS and RTrack 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 deliverablesFoundational 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 trialsStrong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracyMotivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSCExperience with Git-based version control and maintaining analysis documentation.Ability to produce validated, traceable, and reproducible analysis outputs under SOPs and quality systems.ThriveWhat you can expect of usAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsYour 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 nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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..
Locations
- Taiwan - Taipei
Skills Required
- clinical developmentintermediate
- SQLintermediate
- developing analysis datasetsintermediate
- Git-based version controlintermediate
Required Qualifications
- Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics,or related field OR (degree in computer science)
- Bachelor’s degree and 2 years of directly related experience OR (experience, 2 years)
- Associate’s degree and/or 4 years of directly related experience OR (experience, 4 years)
- High school diploma / GED and 6 years of directly related experience (experience, 6 years)
- At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience (experience)
- Experience in SQL, and statistical programming using SAS and R (experience)
- Track record establishing analysis standards, QC/QA processes, and controlled change management. (experience)
- Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables (experience)
- Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals). (experience)
- Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials (experience)
- Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy (experience)
- Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC (experience)
- Experience with Git-based version control and maintaining analysis documentation. (experience)
- Ability to produce validated, traceable, and reproducible analysis outputs under SOPs and quality systems. (experience)
- Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics,or related field OR (degree in computer science)
- Bachelor’s degree and 2 years of directly related experience OR (experience, 2 years)
- Associate’s degree and/or 4 years of directly related experience OR (experience, 4 years)
- High school diploma / GED and 6 years of directly related experience (experience, 6 years)
- At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience (experience)
- Experience in SQL, and statistical programming using SAS and R (experience)
- Track record establishing analysis standards, QC/QA processes, and controlled change management. (experience)
- Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables (experience)
- Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals). (experience)
- Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials (experience)
- Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy (experience)
- Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC (experience)
- Experience with Git-based version control and maintaining analysis documentation. (experience)
- Ability to produce validated, traceable, and reproducible analysis outputs under SOPs and quality systems. (experience)
Responsibilities
- 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 world’s 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 bachelor’s 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.
- 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
- 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
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