Senior Clinical Data Specialist
21 hours ago
Job Description:
We are seeking a Senior Clinical Data Specialist to join our team. As a key member of our data management team, you will be responsible for the development and validation of analysis datasets, tables, listings, and figures for safety and efficacy parameters.
Key Responsibilities:
- Create and/or review derive data specifications as per standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets.
- Perform development and validation of analysis dataset, 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 are compliant with 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.
Required Skills and Qualifications:
- Strong understanding of clinical data standards (SDTM, ADaM)
- Proficient in R Programming or Python
- Excellent analytical and problem-solving skills
- Ability to meet deadlines and manage multiple tasks
Benefits:
This role offers the opportunity to work with a dynamic team and contribute to the development of high-quality clinical data solutions. You will have the chance to work on diverse projects, develop your skills, and advance your career in a supportive and collaborative environment.
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