Clinical Trial Data Expert
2 days ago
We are seeking a highly skilled data professional to support complex statistical programming activities for clinical trials.
This role involves end-to-end SAS programming for analysis and reporting, focusing on regulatory compliance, data standards, and high-quality deliverables.
- Perform data manipulation, analysis, and reporting of clinical trial data using advanced SAS techniques.
- Generate and validate SDTM and ADaM datasets according to CDISC standards.
- Create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions.
- Develop complex ad-hoc reports from raw clinical data.
- Apply strong understanding of efficacy analyses and clinical endpoints.
- Contribute to preparation and review of submission documents and electronic Case Report Tabulations (eCRTs).
- Perform production programming and quality control to ensure accuracy and consistency.
Required Qualifications:
- Bachelor's or Master's degree in Life Sciences, Statistics, Computer Science, or related field.
- 7+ years of hands-on experience in clinical trial programming using advanced SAS techniques.
- Proficient in CDISC standards (SDTM, ADaM), including mapping and validation.
- Strong working knowledge of Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH.
- Experience generating datasets and outputs for regulatory submissions (including ISS/ISE).
- Familiarity with eCTD standards, including Define.xml and dataset documentation.
- Excellent attention to detail and strong analytical problem-solving skills.
Why Work with Us?
Join a collaborative team environment where your expertise in clinical data programming contributes to advancing global healthcare. We value precision, integrity, and innovation in every project we undertake.
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