Tech Stack

Description

In this hybrid role based in NJ/PA, you will work directly for a sponsor while benefiting from the support and career opportunities of a global CRO. You will oversee and create SDTM deliverables for clinical trial analysis, reporting, and regulatory submissions, collaborating with project teams and ensuring data standards compliance.

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, or Engineering with 5+ years SAS programming in clinical trials
• MS in a relevant field with 3+ years SAS programming in clinical trials
• Strong knowledge of SDTM standards and regulatory submission requirements
• Experience with Pinnacle 21 Enterprise
• Ability to work independently and establish high-trust client relationships

Responsibilities

• Create and validate SDTM deliverables including datasets, Define.XML, SDRG, and aCRF
• Assist project teams in preparing submission deliverables using Pinnacle 21 Enterprise
• Manage up-versioning activities to specific SDTM versions
• Collaborate with project stakeholders including statistical programming and data management
• Participate in industry teams and conferences on best practices