Data Standards Specialist
1 week ago
Job Description:
Create and Derive Data Specifications- Develop data specifications as per standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets to ensure accuracy and compliance.
- Validate analysis datasets, tables, listings, and figures for safety and efficacy parameters to meet project requirements.
Responsibilities:
Key Responsibilities- Understand and comply with ICH-GCP guidelines, core operating procedures, and work instructions to maintain high-quality deliverables.
- Ensure all programs are compliant with SOPs and project-specific guidelines to prevent errors and delays.
Requirements:
Required Skills and Qualifications- Experience with R Programming or Python to develop and validate analysis datasets and reports.
Benefits:
Maintain quality and timelines of programming-related deliverables, update project documentation regularly, and track issues raised to ensure smooth project execution.
We are looking for a skilled Data Standards Specialist to join our team. As a key member, you will be responsible for creating and deriving data specifications, validating analysis datasets, and ensuring compliance with industry standards and company policies.
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