Senior Statistical Programmer/Analyst Consultant (TA - Gene Therapy)

Location: United States; remote

Company

hirify.global is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Lead statistical programming activities for gene therapy clinical trials from study start-up through database lock, analysis, and reporting.
• Develop, review, and validate SAS programs and clinical datasets for SDTM, ADaM, tables, listings, and figures.
• Collaborate with Biostatisticians and cross-functional teams on protocols, Statistical Analysis Plans, and programming specifications.
• Support interim and final analyses, database lock activities, Clinical Study Report preparation, and regulatory submissions.
• Manage study-level timelines, deliverables, quality expectations, and programming risks.
• Provide technical guidance and mentorship while participating in client-facing meetings.

Requirements

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Significant clinical trial statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
• Hands-on experience supporting gene therapy clinical trials is required.
• Strong SAS programming skills and knowledge of CDISC standards, including SDTM and ADaM.
• Experience developing and validating clinical trial TLFs and independently leading study-level programming activities.
• Understanding of clinical trial processes, statistical analysis, regulatory reporting, and quality control.

Culture & Benefits

• Work directly with a single sponsor while receiving the career opportunities and security of a global CRO.
• Client-facing work in a high-trust, collaborative environment.
• Continuous training and professional development support.
• Work alongside more than 4,000 professionals across over 20 countries.
• Inclusive, diverse, and equal-opportunity workplace.

Hiring process

• CV submission is followed by an application acknowledgement.
• Qualified candidates are invited to a phone interview as the first step.