Biostatistics Manager

AmgenTaiwan - TaipeionsiteSalary not postedView the original posting at Amgen ↗

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 Biostatistics Manager in Taipei, Taiwan. Live What you will do Amgen is expanding its global Biostatistics capabilities, with Amgen Taiwan playing a key role in integrated delivery and functional leadership. As a Biostatistics Senior Associate, you will provide hands-on statistical expertise to clinical studies across the drug development lifecycle. You will author and review statistical documents, perform data analyses, and collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and timely delivery of study outputs. This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork. Responsibilities: Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications Ensure statistics sections of the TMF are maintained and up-to-date Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights Contributes to defining signal detection threshold Manages self and collaborates closely with peers to ensure timely and quality deliverables Reviews deliverables from external suppliers for quality Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field Assisting in the review of Amgen Policies, SOPs, and other controlled documents Contributing to process improvement initiatives and operational efficiencies. Manage self and other resources according to priorities Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies. Assist with the development and implementation of technology that utilizes AI to streamline statisticians' work. Win What we expect of you Basic Qualifications : MSc or PhD in Statistics, Biostatistics, or related field. ~3–5 years relevant industry experience. Proven ability to apply statistical methods in clinical development. Preferred Skills : Doctorate degree in Statistics/Biostatistics Experience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applications Life-cycle drug development experience Experience working effectively in a globally dispersed team environment with cross-cultural partners. 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 oppo

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