Senior Director, Statistical Programming

Role Summary

The Senior Director, Statistical Programming is a key leadership role responsible for overseeing the design, development and delivery of statistical programming solutions across all clinical trials conducted by Arcellx. Your work will have a direct impact on our ability to successfully navigate our trials and get our transformative therapy to patients.

Responsibilities

• Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs.
• Review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines.
• Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
• Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
• Oversee and manage work of other programmers.
• Develop and/or validate standard macros to automate output production.
• Assist with infrastructure development of the department.

Qualifications

• BS/BA degree in related discipline.
• 13+ years of experience in statistical programming with clinical data and SAS.
• Experience in oncology therapeutic area preferred.
• Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros.
• CDISC expertise required.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Excellent interpersonal communication skills.

Skills

• Statistical programming
• CDISC standards (SDTM/ADaM)
• SAS, including Macro language
• Leadership and people management
• Regulatory guidelines experience (CDISC/FDA)

Education

• BS/BA degree in related discipline.

Additional Requirements

• On-site or hybrid collaboration with teams in multiple locations as applicable