Position Details
About this role
This role involves overseeing the quality and standards of clinical submission data, ensuring compliance with regulatory requirements, and supporting the preparation of regulatory submissions for drugs and vaccines.
Key Responsibilities
- Manage submission data standards
- Coordinate with project teams
- Ensure data quality and conformance
- Prepare for regulatory meetings
- Support electronic submission processes
Technical Overview
Utilizes SAS programming, clinical data standards (SDTM, ADaM), Pinnacle 21 Enterprise, and data quality tools to manage electronic submission data and ensure regulatory compliance.
Ideal Candidate
The ideal candidate is a senior statistical programmer with 5+ years of SAS experience in clinical trial data standards and regulatory submissions. They should be familiar with SDTM, ADaM, and Pinnacle 21 for data quality and compliance.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
No SAS programming experience, Lack of clinical data standards knowledge, No experience with regulatory submissions, Less than 5 years of relevant experience
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