Associate Director, Statistical Programming

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as the Associate Director, Statistical Programming. Lead statistical programming activities across clinical development programs, building internal capabilities and ensuring high-quality deliverables. Collaborate with internal stakeholders and vendors, perform CDISC compliance checks, and program ad hoc datasets. This role offers the opportunity to build a programming infrastructure from the ground up as the first statistical programming team member. Work remotely is an option. The company is committed to elevating patient care and fostering a supportive culture.

Requirements

• Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, or related field
• Strong proficiency in SAS programming; experience with R or Python a plus
• In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines
• Strong attention to detail and commitment to producing high-quality, audit-ready deliverables
• Excellent organizational and communication skills with a proactive, solution-oriented mindset
• Ability to work effectively in a lean, cross-functional, start-up environment

Responsibilities

• Lead the development, validation, and documentation of statistical programming deliverables (e.g., SDTM, ADaM datasets, tables, listings, and figures) for clinical studies and regulatory submissions
• Collaborate with internal teams and CRO partners to ensure quality, consistency, and compliance with CDISC standards and regulatory requirements
• Serve as the primary programming lead across multiple studies or clinical programs
• Develop and maintain programming standards, tools, and processes to support scalable clinical development
• Provide strategic input to study design, data flow, and database structures from a programming perspective
• Review and provide input on protocols, statistical analysis plans (SAPs), CRFs, and data specifications
• Support preparation of regulatory documents including clinical study reports (CSRs), ISS/ISE, and responses to health authority questions
• Partner with biostatistics, data management, medical writing, regulatory, clinical development, and clinical operations teams to ensure alignment of timelines and deliverables
• Contribute to vendor selection, oversight, and performance management related to programming activities

Preferred Qualifications

Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings preferred

Benefits

We are open to you working remotely