Position Summary:
The Principal Programmer02will work in BeiGene’s Statistical Programming group to manage and support Statistical Programming deliverables for multiple clinical studies. 02
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Essential Duties & Responsibilities:

Technical lead and project manager for one or multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines
Provide input to study resource needs
Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications as needed
Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities
Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.
Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents
Interface with outsourcing partners and vendor
Other duties as assigned


Core Competencies, Knowledge and Skill Requirements:

Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADAM datasets (as needed)
Computer programming using SAS
Fundamentals of project planning and management
Drug development process


Communication & Interpersonal Skills:

Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment



DESIRED BACKGROUND AND EXPERIENCE (Include License or Certifications)

Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
Expert level knowledge and extensive hands-on experience of CDISC methodologies
Experience leading or working with centralized teams for Statistical Programming
Experience in Oncology Trials
Experience in FDA/EMEA/CFDA trial and regulatory submissions
Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research


REQUIREMENTS
Education:

Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience


Experience:

Minimum 2-5 years’ clinical research and development programming experience using SAS


Licenses or Certifications:

N/A


百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
●Fosters Teamwork
●Provides and Solicits Honest and Actionable Feedback
●Self-Awareness
●Acts Inclusively
●Demonstrates Initiative
●Entrepreneurial Mindset
●Continuous Learning
●Embraces Change
●Results-Oriented
●Analytical Thinking/Data Analysis
●Financial Excellence
●Communicates with Clarity
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