About Us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit
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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description
Position Summary:
The Principal Programmer will work in BeiGene's Statistical Programming group to manage and support Statistical Programming deliverables for multiple Real-World Evidence (RWE) and clinical studies.
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
- Support the execution of RWE studies utilizing real-world data sources, including claims, electronic health records (EHRs) and registry data by applying best practice in RWD programming
- 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
Qualification Required
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 R, SQL or SAS
- Basic knowledge of statistical analysis methodologies and study design concepts
- Fundamentals of project planning and management
- Drug development process
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Excellent problem-solving skills and ability to work independently and collaboratively in a fast-paced environment
Desired Background And Experience (Include License Or Certifications)
- Expert level R, SQL or SAS programmer with demonstrated experience in handling large-scale healthcare datasets and delivering on complex programming assignments and analysis
- Expert level knowledge and extensive hands-on experience of CDISC methodologies
- Experience in supporting HEOR, epidemiology or medical affairs teams
- 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
Education
- Master's degree, in Computer Science, Statistics, Mathematics, Epidemiology, Life Sciences or other relevant scientific subject, or equivalent related experience
Experience
- Minimum 5+ years' clinical research and development programming experience using R or SQL, SAS
Licenses Or Certifications
N/A
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career
BeOne Global Competencies
When we exhibit our values of Patients First, 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
BeOne
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