Description

You will perform complex programming and data management within clinical research settings, owning the development of analysis datasets, TLGs, and e-submission components.

This role is remote.

Responsibilities

• Develop and implement SAS code for analysis datasets, TLGs, and e-submission components.
• Apply SDTM and ADaM standards to manage clinical trial data.
• Ensure deliverables meet industry standards for regulatory submission.
• Work independently to manage and deliver assignments on time and to quality standards.

Required Skills

• Expert proficiency in SAS programming and problem-solving.
• Deep knowledge of ADaM standards across all aspects.
• Mandatory experience with regulatory submissions.
• Knowledge of government regulations, specifically CDISC and ICH guidelines.
• Solid understanding of SDTM and ADaM implementation guides.
• Experience with Pinnacle 21, XML, and MS Office.
• 7+ years of relevant pharmaceutical or clinical research programming experience (or equivalent Master's level experience).

Preferred Skills

• Advanced knowledge of CDISC e-submission deliverables (ISS/ISE, BIMO).
• Familiarity with statistical models for efficacy data analysis.

Key Skills

Education

Bachelor's or Master's degrees