Associate Director, Scientific Programming

The Senior Manager, Statistical Programming Project Lead at BeOne is responsible for leading global statistical programming efforts across multiple clinical development programs, ensuring high-quality deliverables and regulatory compliance.

Location: United States

Salary: $144,400.00 - $189,400.00 annually

Responsibilities

• Collaborate with lead project Biostatistician in project strategic planning and provide guidance to the programming team.
• Represent the statistical programming team at Study Management Team and Clinical Development meetings.
• Contribute to programming resource algorithms and project resource planning.
• Interact and communicate with various clinical and data teams to address programming deliverables.
• Contribute to strategies for regulatory submissions, publications, and communications.
• Understand and execute department-, product- and study-level macros and utilities.
• Provide advice on complex programming tasks and standards.
• Assist in review of key study-related documents.
• Oversee creation of analysis datasets, production/validation of output, and review of annotated case report forms.
• Support regulatory submissions following CDISC standards.
• Contribute to departmental process and standards initiatives.
• Support the selection and management of CROs.
• Oversee work supporting clinical trials, ad-hoc analysis, data validation.
• Lead the development of TAUG following CDISC standards.
• Perform other duties as assigned.

Requirements

• Master’s degree in a quantitative or scientific field (e.g., Computer Science, Statistics, Mathematics, Life Science) preferred with 5+ years of relevant experience.
• Experience with CDISC standards (SDTM, ADaM).
• Familiarity with regulatory submission deliverables (e.g., TFLs, ISS/ISE, eCTD).
• Knowledge of clinical data structures and study designs.
• Experience with ClinPharm/PK analyses.
• Familiarity with workflow automation and reproducibility.
• Ability to oversee multiple studies or programs.
• Vendor/CRO oversight experience.
• Cross-functional collaboration with Statistics, Clinical, Data Management, Clinical Pharmacology, Medical Writing, and Regulatory.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness.