Executive Director, Statistical Programming & Submissions

4DMT; United States; On-site; USD 298,000 - 340,000; Full time

Job summary

4DMT seeks an Executive Director of Statistical Programming to lead programming across development programs, ensuring high-quality analyses for regulatory submissions and robust data standards.

You will collaborate with Biostatistics, Data Management, Regulatory, and IT, guiding outsourcing teams, building scalable processes, and driving strategic initiatives in ophthalmology and gene therapy programs.

Qualifications

• Minimum 17+ years in statistical programming, biometrics or clinical development, with leadership experience.
• Experience leading programming strategy for regulatory submissions (BLA/IND or equivalent).
• 8+ years in management, scaling in-house programming teams.
• Experience in ophthalmology or biologic/gene therapy is a plus.

Responsibilities

• Provide strategic and operational leadership for statistical programming across development programs.
• Review SAPs and develop clear data/analysis programming specifications.
• Ensure auditable, inspection-ready programming documentation for analyses and submissions.
• Lead development and governance of reusable programming standards and templates.
• Define and maintain fit-for-purpose statistical computing infrastructure (SAS server and tools).
• Provide biometrics leadership on select projects and cross-functional initiatives.
• Collaborate to ensure robust CRF/EDC development and data collection.
• Oversee biometrics vendors and external programming partners for quality and timeliness.
• Ensure quality review of outsourced deliverables and coordinate internal reviews.
• Develop function-level standards, SOPs and continuous improvement initiatives.
• Stay abreast of biostatistics and data standards and apply advancements.

Skills

SAS programming

R programming

Microsoft Office

CDISC standards

Regulatory submissions

Leadership & vendor oversight

Clinical trial knowledge

Regulatory knowledge (GCP/ICH/HIPAA)

Education

B.S. in statistics or quantitative science

Advanced degree preferred

Tools

SAS/BASE

SAS Macros

SAS/STAT

ODS

Job description

4DMT seeks an Executive Director of Statistical Programming to lead programming across development programs, ensuring high-quality analyses for regulatory submissions and robust data standards.

You will collaborate with Biostatistics, Data Management, Regulatory, and IT, guiding outsourcing teams, building scalable processes, and driving strategic initiatives in ophthalmology and gene therapy programs.