(Senior) Principal Statistical Programmer

BeiGene

8d•$144,400 - $189,400

About The Position

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.

Requirements

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.
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.

Responsibilities

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.