Senior Manager, Clinical & Statistical Programming (Biotech)

Location: Remote within the United States; ideally based in Seattle, Washington, with onsite work at least 2 days per week. Remote employees may travel up to 10% as needed.

Salary: $170,000–$210,000 per year

Company

hirify.global is a biotechnology company developing integrated immunotherapy platforms and off-the-shelf cancer treatments.

What you will do

• Plan, execute, and quality-check clinical and statistical programming deliverables across the full clinical trial lifecycle.
• Provide hands-on SAS programming for safety, efficacy, exploratory, and publication analyses.
• Review protocols, statistical analysis plans, CRF designs, EDC deployments, data management plans, and data transfer plans.
• Guide CRO and contractor outputs, including SDTM and ADaM datasets, programs, TLFs, define.xml, and reviewer guides.
• Support IND, NDA, and BLA regulatory submissions, audits, inspections, and regulatory inquiries.
• Build biometrics infrastructure, including macros, programs, TLF shells, SOPs, best practices, and data traceability processes.

Requirements

• BS in biostatistics, statistics, computer science, or a closely related field.
• At least 8 years of experience in pharmaceutical companies or CROs, with clinical programming and quantitative analysis experience.
• Advanced SAS programming skills and substantial experience preparing regulatory submission packages.
• Strong knowledge of CDISC standards, ICH, FDA, and GCP regulations and guidelines.
• Experience leading projects and guiding cross-functional teams, with excellent communication and attention to detail.
• Must be able to work remotely from within the United States; the Seattle office option requires onsite attendance at least 2 days per week.

Nice to have

• Master's degree.
• NDA or BLA submission experience and interaction with regulatory agencies.
• Experience leading early- and late-phase clinical trials.
• Immunology, hematology, or oncology clinical trial experience.
• Experience using R for clinical analysis.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with a 100% match on the first 4% of employee deferrals.
• Paid time off, commuter benefits, and a cell phone stipend.
• Work in newly built facilities in Seattle and Louisville within a growing biotechnology organization.