Job
Description
SAS Programming: Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures. Perform programming validation to ensure the quality of analysis datasets and programming outputs i.e. Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Project Support: Provide programming support for project teams, including the development of programming strategies, standards, specifications, and programmed analysis. Submission Preparation: Support the preparation and review of electronic submissions. Experience in writing programming specifications for SDTM and ADaM. Document Review: Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess the impact on programming activities. Vendor Interaction: Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers. Efficiency Improvement: Identify opportunities for increased efficiency and consistency and interactions with strategic vendors. Skills, Knowledge, and Experience: Education: Bachelors degree in statistics, biostatistics, mathematics, computer science, or life sciences. Experience: At least 8 years of programming experience in the clinical industry. Analytical Programming: Demonstrated proficiency in analytical programming. Clinical Data Structure: In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases. Data Handling: Demonstrated ability in handling and processing upstream data (e.g., multiple data forms, workflow, eDC, SDTM). Output Provision: Demonstrated ability in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission). Regulatory Knowledge: Good understanding of regulatory, industry, and technology standards and requirements. Statistical Knowledge: Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Very strong SAS programming skills required in SAS/Base, PROC SQL, SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS).
