Biostatistical Programming Manager

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 Manager in Taipei, Taiwan. Live What you will do Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen Taiwan playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions. Key Responsibilities: Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team Participate in establishing the programming scope for a deliverable with statisticians and study team Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects Representing GSP at the Clinical Study Team (CST) Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications Initiate cross-functional team meetings as necessary Perform significant hands-on statistical programming, particularly for those most challenging deliverables Manage individual programmer work assignments to ensure timely, high-quality deliverables Provide technical leadership and guidance for study programming team Coordinate and monitor data issue reporting and resolution Coordinate with other SLPs to provide consistent deliverables across studies within a product Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.) Provide training and guidance to other programmers Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL). 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 5 years of statistical programming experience in clinical development environment. Thorough understanding of clinical trial processes, from data collection to analysis reporting Proven record of superior statistical programming and problem-solving skills within clinical development environment Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards Advanced analysis and reporting skills in SAS and/or R, including SAS/STAT and/or R packages, among others Experience in data quality and compliance check tools Excellent project management skills and ability to lead multiple projects effectively Excellent oral and written English communication skills Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners Willingness and ability to provide guidance to team members on technical and process questions 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. .