Senior Statistical Programming Lead - Hybrid CA

Vividion; San Diego (CA); Hybrid; USD 180,000 - 220,000; Full time

Job summary

Vividion seeks an Associate Director, Statistical Programming in San Diego to lead programming for clinical analyses using SAS, review deliverables, and mentor CROs. You will shape standards, drive ADaM/SDTM processes, and ensure compliance with CDISC and FDA/ICH requirements.

You will collaborate with the Biometrics Team, Clinical Operations, Regulatory, and CROs to deliver high-quality analyses and submissions for multiple studies.

Qualifications

• Bachelor’s or MS in statistics, biostatistics, mathematics, computer science or life sciences.
• At least 8 years programming experience in industry including support of regulatory filings.
• Proficient knowledge of drug development, trial methodology, regulatory guidance and CDISC standards.
• Experience with SAS to produce analysis datasets and TFLs; familiarity with SDTM/ADaM.

Responsibilities

• Provides comprehensive programming leadership to clinical project teams including standards and programmed analyses.
• Oversees CRO SAS programming to ensure timely delivery and quality.
• Oversees CRO development of SAS programs for SDTM/ADaM data sets and Tables, Listings and Figures.
• Leads statistical programming activities across multiple studies and supports submission preparation.
• Develops robust programming specifications and communicates risks and issues proactively.

Skills

SAS leadership

CDISC/CDISC Standards

Regulatory filings

Team collaboration

Programming leadership

Education

Bachelor’s or MS in statistics/biostatistics/math/computer science/life sciences

Tools

SAS

Pinnacle 21

XML

MS Office

Job description

Vividion seeks an Associate Director, Statistical Programming in San Diego to lead programming for clinical analyses using SAS, review deliverables, and mentor CROs. You will shape standards, drive ADaM/SDTM processes, and ensure compliance with CDISC and FDA/ICH requirements.

You will collaborate with the Biometrics Team, Clinical Operations, Regulatory, and CROs to deliver high-quality analyses and submissions for multiple studies.