Director of Statistical Programming

What You'll Do

The Director of Statistical Programming will lead statistical programming activities for multiple studies and programming submission-related activities. In addition to working as a hands-on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.

Responsibilities

(5-7 bullets max)

• Lead and manage statistical programming activities for multiple clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
• Review CRO deliverables and perform acceptance check and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards 
• Manage, review, and/or execute statistical programming deliverables related to study monitoring, clinical study reports, data integrations, and regulatory query responses
• Collaborate with external alliances for all programming-related tasks to ensure successful and effective coordination and communications

• Set up SAS reporting environment, programming infrastructure, and utility macros library; Help bring state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI-assisted tools to improve programming efficiency, quality, regulatory and GDPR compliance

• Represent the statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines
• Identify, develop and maintain statistical programming standards, processes, and SOPs.

Where You'll Work

This is a U.S.-based remote role that will require bi-annually, or as needed visits to our San Francisco Office.

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

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• MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience. Minimum of 5 years of experience as a lead statistical programmer
• Extensive knowledge of CDISC standards and FDA SDTCG
• Experience of CRO oversight preferred
• Experience in NDA/BLA submission and advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
• Experience with statistical programming methods and processes in clinical development
• Ability to manage multiple projects in a fast-paced environment

• Experience integrating AI tools into clinical data pipelines and statistical workflows is highly desirable