Senior Statistical Programming Lead – Oncology (Remote)

Avenzo Therapeutics, Inc.; San Diego (CA); Hybrid; USD 184,000 - 197,000; Full time

Job summary

Avenzo Therapeutics, Inc. is seeking an Associate Director, Statistical Programming in San Diego or Remote U.S.

You will lead hands-on SAS programming, oversee CROs, ensure CDISC SDTM/ADaM compliance, and support regulatory submissions for early and late-phase oncology programs. The role reports to the Senior Director, Statistical Programming and requires 8+ years in life sciences with CDISC and SAS expertise, plus strong communication and leadership skills.

Qualifications

• 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
• Excellent written and verbal communication skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Responsibilities

• Provide statistical programming leadership, timelines, vendor oversight, and delivery of compliant outputs (e.g., FDA 21 CFR Part 11, GxP)
• Lead CDISC datasets (SDTM, ADaM), TLFs regulatory submissions, SAPs, and supporting documents
• Oversee programming support for 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
• Collaborate with internal and external stakeholders

Skills

SAS programming

CDISC standards

Statistical programming

Leadership

Regulatory submissions

Education

Bachelor's degree

MS/PhD preferred

Tools

SAS

Job description

Avenzo Therapeutics, Inc. is seeking an Associate Director, Statistical Programming in San Diego or Remote U.S.

You will lead hands-on SAS programming, oversee CROs, ensure CDISC SDTM/ADaM compliance, and support regulatory submissions for early and late-phase oncology programs. The role reports to the Senior Director, Statistical Programming and requires 8+ years in life sciences with CDISC and SAS expertise, plus strong communication and leadership skills.