Executive Director, Statistical Programming

Location: Remote, United States

Base salary: $298,000–$340,000 per year

Company

hirify.global is a biotechnology company developing targeted gene therapies using proprietary AAV vector evolution technology.

What you will do

• Provide strategic and operational statistical programming leadership across clinical development programs, trials, and regulatory submissions.
• Partner with Biostatistics, Data Management, Clinical Development, Regulatory, Clinical Operations, Quality, IT, and external vendors.
• Lead the development, governance, documentation, and maintenance of reusable programming code, standards, templates, SOPs, and best practices.
• Ensure complete, auditable, inspection-ready programming documentation and quality review of outsourced statistical deliverables.
• Define statistical computing infrastructure requirements, including the SAS server environment and related tools.
• Set programming strategy, resource priorities, quality expectations, and risk mitigation plans while communicating decisions to senior stakeholders.

Requirements

• Bachelor’s degree in statistics, computer science, or another quantitative science discipline; an advanced degree or equivalent experience is preferred.
• 17+ years of relevant statistical programming, biometrics, or clinical development experience, including leadership in clinical development and regulatory submissions.
• 8+ years of management experience, including scaling an in-house programming team.
• Expert SAS programming skills, including SAS/BASE, SAS Macros, SAS/STAT, and ODS.
• Strong knowledge of clinical trial standards, including CDISC, SDTM, ADaM, CDASH, MedDRA, and WHODrug.
• Experience with BLA/IND or equivalent global health authority submissions and submission-related regulatory requirements.

Nice to have

• Experience in ophthalmology, biologics, or gene therapy.
• Proficiency in R, SAS/SQL, SAS/GRAPH, or SAS/ACCESS.
• Experience across Phase I, II, III, and IV clinical development.
• Knowledge of P21 checks, GCP, FDA, CHMP, ICH, HIPAA, eCTD, and CRT packages.

Culture & Benefits

• Remote work arrangement with less than 5% travel.
• Collaborative environment supporting individual contributions and cross-functional work.
• Generous benefits and opportunities for career development.
• Mission-driven work focused on developing gene therapies for genetic and rare diseases.