Core Responsibilities:
- SAS Programming:
- TFL Generation:Develop and manage SAS programs for the generation of Tables, Listings, and Figures (TFLs).
- Macros:Design, develop, and validate standard and ad-hoc SAS macros for various analytical needs.
- Data Validation:
- Safety Tables:Validate safety tables using SAS to ensure accuracy and consistency.
- ADaM Datasets:Prepare and validate Analysis Data Model (ADaM) datasets and their specifications.
- SDTM Datasets:Validate Study Data Tabulation Model (SDTM) datasets and their specifications.
- Statistical Input:
- CRF Design:Provide statistical and programming inputs for Case Report Form (CRF) design and review.
- Analysis Plans:Review statistical analysis plans (SAP) to ensure alignment with study objectives and requirements.
- Documentation and Review:
- CRF/aCRF Review:Review and assess CRF and annotated CRF (aCRF) to ensure completeness and accuracy.
- Programming Specifications:Prepare and review programming specifications for efficacy variables.
- Training and Compliance:
- Training:Adhere to required training programs and keep skills updated to meet evolving industry standards.
Desirable Skills and Experience:
- SAS Expertise:Extensive experience with SAS programming and statistical analysis.
- SDTM & ADaM Expertise:Subject matter expert in SDTM and ADaM datasets.
- Attention to Detail:Strong ability to ensure data accuracy and validate complex datasets.
- Analytical Skills:Proficiency in preparing and reviewing statistical analysis plans and programming specifications.
- Communication:Effective in providing clear documentation and collaborating with cross-functional teams.
