Tech Stack

Description

You will lead statistical programming activities for clinical trials, producing and validating tables, listings, figures, and analysis datasets. You'll collaborate with cross-functional teams and oversee CROs to ensure accurate, regulatory-compliant data outputs.

Requirements

• Master's degree in statistics, mathematics, computer science or related field
• 8+ years SAS statistical programming in clinical trials (industry/CRO)
• Advanced SAS skills: Macro, BASE, STAT, GRAPH; experience with CDISC SDTM/ADaM
• Oncology experience required
• In-depth knowledge of regulatory guidelines (FDA, EMA, ICH) and submission standards

Responsibilities

• Lead programmer for tables, listings, figures, and analysis datasets for regulatory and publication requests
• Develop and review TFL shells, SDTM and ADaM specifications with biostatisticians
• Ensure accuracy of final databases, analyses, and reports with Data Management and Biostatistics
• Oversee CROs and programming vendors for outsourced activities
• Manage project timelines and develop global tools to improve programming efficiency