Strategic Leader, Statistical Programming & Submissions

BioSpace; United States; On-site; USD 298,000 - 340,000; Full time

Job summary

4DMT seeks an Executive Director of Statistical Programming to lead statistical programming across development programs, guiding in-house deliverables and ensuring quality for regulatory submissions.

This senior role partners with Biostatistics, Data Management, Clinical Development and IT to plan, prioritize and execute activities, establish standards, and advance data standards and automation.

Qualifications

• 17+ years in statistical programming or biometrics or clinical development
• Experience leading statistical programming strategy for regulatory submissions (BLA/IND)
• Strong leadership and cross-functional collaboration skills

Responsibilities

• Provide strategic and operational statistical programming leadership for assigned indications and development programs
• Review SAPs and ensure data and programming specifications are clear and fit-for-purpose
• Ensure auditable, inspection-ready programming documentation for analyses and submissions
• Lead development of reusable code, standards, templates, and best practices
• Oversee programming infrastructure and governance for SAS environments
• Collaborate with cross-functional teams to ensure robust CRF/EDC development and data quality

Skills

SAS programming

R programming

CDISC standards

Regulatory submissions

Leadership

Education

B.Sc./M.S. in statistics or related field

Advanced degree preferred

Tools

SAS Server

SAS Macros

SAS/STAT

Job description

4DMT seeks an Executive Director of Statistical Programming to lead statistical programming across development programs, guiding in-house deliverables and ensuring quality for regulatory submissions.

This senior role partners with Biostatistics, Data Management, Clinical Development and IT to plan, prioritize and execute activities, establish standards, and advance data standards and automation.