Top Skills' Details
The Statistical Programmer is responsible for supporting the Biostatistics and Statistical Programming team in delivering high-quality SAS programming services. Key duties include the development and review of SAS programs and outputs to effectively manage and report clinical trial data. This role involves collaboration with cross-functional teams to ensure accuracy and compliance with regulatory standards.
Job Description
Assist in the development and validation of SAS programs for data analysis, data manipulation, and reporting.
Create datasets for analysis using SDTM and ADaM standards.
Develop specifications for SDTM and ADaM datasets with guidance from sr programming staff
Generate tables, listings, and figures (TLFs) for clinical study reports.
Collaborate with medical science team to ensure the accuracy and consistency of clinical trial data.
Participate in the review of study protocols, statistical analysis plans, and other relevant documentation.
Debug and resolve data and programming issues in a timely manner.
Use efficient programming techniques to produce/ quality control derived datasets (e.g. SDTM, ADaM), tables, figures, and listings.
Maintain and expand regulatory knowledge within the clinical industry.
Stay updated with clinical trial regulations and programming best practices.
Develop knowledge of areas of CDISC standards, Electronic Data Capture (EDC), SAS, etc.
Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations.
Proactively participate in process/quality improvement initiatives
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