(Senior) Principal Statistical Programmer

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.

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