Sr. Statistical Programmer
1 day ago
- Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
- Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
- Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
- Development and review CDISC SDTM and ADaM mapping specifications.
- Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
- Review datasets for any pending compliance issues and meticulously document identified issues.
- Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
- Generation of utility macros and efficient code writing to streamline programming processes.
- Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
- Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 4 years of SAS programming experience. Alternatively, a bachelor's degree with at least 6 years of SAS programming experience.
- minimum of 2 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.
- Proficiency in SAS Programming.
- Previous involvement as a production or QC programmer at both product and study levels.
- Strong organizational, interpersonal, leadership, and communication skills.
- bility to autonomously manage multiple tasks and projects.
- In-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
- minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.
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Newark, NJ, United States Rose International Full timeJob Description ***Only qualified Mainframe Systems Programmer candidates located at the Newark, NJ area to be considered due to the position requiring an onsite presence*** Required Skills: • DDM's (7 Years) • Natural Structured Mode language model (7 Years) • Fully versed in ADABAS Dara Access (7 Years) • JCL Batch Processing (7 Years) SUMMARY:...
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