Executive Director, Statistical Programming
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Job Description
Executive Director leading statistical programming for 4DMT’s gene therapy clinical development programs. Overseeing SAS-driven submissions, clinical-trial standards, vendors, and cross-functional biometrics strategy.
Responsibilities:
- Provide strategic and operational statistical programming leadership for assigned indications and development programs
- Partner with biostatisticians and cross-functional stakeholders to review statistical analysis plans and develop data and analysis programming specifications
- Ensure complete, auditable, inspection-ready programming documentation for clinical-trial analyses and regulatory submissions
- Lead development, governance, documentation, and maintenance of reusable programming code, standards, templates, and best practices
- Partner with IT and functional leadership to define and maintain statistical computing infrastructure, including the SAS server environment and related tools
- Provide senior statistical programming expertise and biometrics leadership on selected projects and cross-functional initiatives
- Collaborate on CRF/EDC development and quality data collection for assigned clinical trials
- Oversee biometrics vendors and external programming partners, ensuring timely, high-quality deliverables, issue escalation, and accountability
- Conduct or coordinate quality review of outsourced statistical deliverables, including in-house double programming or quality control as needed
- Lead or contribute to function-level standards, SOPs, work instructions, templates, and continuous improvement initiatives
- Monitor industry developments in biostatistics, statistical programming, regulatory expectations, automation, and data standards
- Establish programming strategy, resource priorities, quality expectations, and risk mitigation plans, and communicate decisions and escalations to senior stakeholders
- Perform other duties as assigned
- Work in primarily sedentary conditions with typical office or administrative environmental exposure
Requirements:
- A./B.S. degree in statistics, computer science, or another quantitative science major required
- 17+ years of relevant statistical programming, biometrics, or clinical development experience, including significant leadership experience in clinical development and regulatory submissions
- Demonstrated experience leading statistical programming strategy and execution for regulatory submissions, including BLA/IND or equivalent global health authority submissions
- 8+ years of management experience, including scale-up of an in-house programming team
- Expert SAS programming skills, including SAS/BASE, SAS Macros, SAS/STAT, and ODS
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint
- Strong understanding of clinical-trial standards, including CDISC, SDTM, ADaM, CDASH, MedDRA, and WHODrug
- Knowledge of applicable GCP, FDA, CHMP, ICH, and HIPAA regulations
- Less than 5% travel
- Advanced degree preferred, or equivalent experience
- Experience in ophthalmology and/or biologic/gene therapy a plus
- Proficiency in SAS/SQL, SAS/GRAPH, SAS/ACCESS, R, Excel/PowerPoint Chart features, P21 checks, and experience across clinical phases I–IV are desirable or a plus
- Strong organization, prioritization, time management, attention to detail, communication, analytical, strategic, interpersonal, vendor oversight, people leadership, and project management skills
- Ability to identify risks and drive decision-making, escalation, and resolution
- Sedentary work and repetitive wrist, hand, finger, typing, and speaking activities
Benefits:
- Equal employment opportunities without regard to protected characteristics
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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