Head of Statistical Programming & Regulatory Submissions

4D Molecular Therapeutics; United States; On-site; USD 298,000 - 340,000; Full time

Job summary

4D Molecular Therapeutics is seeking an Executive Director of Statistical Programming to provide strategic and operational leadership across development programs. This role will guide in-house deliverables, ensure quality review of outsourced work, and establish scalable standards and processes in collaboration with Biostatistics, Data Management, Clinical Development, Regulatory, and IT teams.

The position requires extensive experience in statistical programming, with leadership in regulatory

Qualifications

• 17+ years in statistical programming/biometrics or clinical development.
• 8+ years of management experience including in-house team expansion.
• Experience leading regulatory submissions (BLA/IND).
• Experience with ophthalmology or biologic/gene therapy is a plus.

Responsibilities

• Provide strategic and operational statistical programming leadership.
• Review SAPs and ensure clear data programming specs.
• Ensure auditable programming documentation for analyses.
• Develop reusable programming code and standards.
• Oversee SAS server environments and related tools.
• Lead biometrics vendors and external partners.

Skills

SAS programming

SAS/BASE

SAS Macros

SAS/STAT

SAS/GRAPH

SAS/SQL

SAS/ACCESS

Regulatory submissions

Leadership

Biostatistics leadership

Education

Bachelor's degree in statistics, computer science, or quantitative science

Advanced degree (M.A./M.S.) preferred, or equivalent experience

Tools

R programming

Microsoft Office (Word, Excel, PowerPoint)

Job description

4D Molecular Therapeutics is seeking an Executive Director of Statistical Programming to provide strategic and operational leadership across development programs. This role will guide in-house deliverables, ensure quality review of outsourced work, and establish scalable standards and processes in collaboration with Biostatistics, Data Management, Clinical Development, Regulatory, and IT teams.

The position requires extensive experience in statistical programming, with leadership in regulatory