Associate Director, Statistical Programming

About the role

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. This position will report to the Senior Director, Statistical Programming.

Responsibilities

• Provide statistical programming leadership, including timelines, vendor oversight, and delivery of compliant outputs (e.g., FDA 21 CFR Part 11, GxP)
• Lead and execute programming deliverables, including CDISC datasets (SDTM, ADaM), TLFs regulatory submissions, SAPs, and supporting documents
• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, and TLFs
• Hands-on programming and management of in-house deliverables
• Experience in statistical programming for early and late phase oncology trial studies
• Proven ability to lead programming for clinical study protocols
• Proficiency in SAS Programming for analysis datasets, tables, listings, and figures

Requirements

• Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• 6+ years of Statistical Programming experience with early or late phase oncology trial studies
• In-depth knowledge of CDISC standards
• Technical expertise and knowledge of statistical analyses using SAS

Preferred Qualifications

• Proactive, innovative mindset with the ability to thrive in a fast paced, team setting, collaborating environment providing programming timelines for various deliverables

Physical Demands and Work Environment

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously