General Description:

The (Senior) Principal Programmer works within BeOne's Statistical Programming group to manage and support Statistical Programming deliverables for multiple clinical studies. The role serves as a technical lead and project manager, partners cross-functionally, and supports high-quality programming outputs for regulatory submissions, publications, and other clinical communications.

Essential Functions of the Job:

• Technically lead and project manage 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.

• Assess resourcing needs and support adequate staffing of projects.

• Assist in reviewing key study-related documents produced by other functions, including statistical analysis plans, case report forms, data management plans, 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 other partners to address programming-related study deliverables.

• Write, test, and validate SAS programs to produce analysis datasets, tables, listings, graphs, and presentation outputs for regulatory submissions, 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.

• Serve as a technical resource for the programming group and provide advice on complex programming tasks and standards.

• Contribute to the development and review of Statistical Programming policies, standard operating procedures, and other controlled documents.

• Interface with outsourcing partners and vendors.

• Perform other duties as assigned.

Supervisory Responsibilities:

Individual contributor role. No direct people-management responsibility is specified. Provides technical leadership and project management for multiple studies, including resource planning and coordination with centralized teams, outsourcing partners, and vendors.

Computer Skills:

• Expert-level SAS programming with experience delivering complex programming assignments and analyses.

• Knowledge of SDTM and ADaM standards, including writing CDISC-standard dataset specifications and creating SDTM and ADaM datasets from specifications.

• Ability to develop, test, and validate analysis datasets, tables, listings, graphs, macros, utilities, and presentation outputs.

Other Qualifications:

• Minimum 5+ years of clinical research and development programming experience using SAS.

• Expert-level knowledge and extensive hands-on experience with CDISC methodologies.

• Experience leading or working with centralized Statistical Programming teams.

• Experience in oncology trials.

• Experience with FDA, EMEA, and CFDA clinical trial and regulatory submissions.

• Experience with the drug development process in preclinical, early, late-stage, and/or observational settings in related industries or academic research.

• Knowledge of the drug development process and fundamentals of project planning and management.

• Excellent verbal and written communication skills and the ability to collaborate effectively in a dynamic environment.

• Licenses or certifications: N/A.

Education Required:

Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject, or equivalent related experience.

Travel:

• Not specified in the source job description.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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 is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.