
Clinical Data Strategist
2 days ago
Job Title: Clinical Data Strategist
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- Create data specifications according to standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
- Develop and validate analysis datasets, tables, listings, and figures for both safety and efficacy parameters.
- Understand and comply with ICH-GCP guidelines, core operating procedures, and work instructions.
- Ensure all programs adhere to SOPs and project-specific guidelines.
- Provide support in developing ad hoc reports as required.
- Maintain quality and timelines of programming-related deliverables.
- Update project-related documentation regularly.
- Track and follow up on all issues raised.
- Experience with R Programming/PYTHON is preferred.
Key Requirements:
- Strong understanding of data management principles and regulatory requirements.
- Ability to develop and maintain complex data specifications.
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- Experience with data visualization tools.
Benefits:
- Competitive salary package.
- Opportunities for career growth and professional development.
- A collaborative and dynamic work environment.
Others:
- Compliance with relevant regulations and industry standards.
- Continuous improvement of processes and procedures.
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