Job
Description
Responsibilities: Develop and validate SAS programs to transform, analyze, and report clinical trial data in accordance with SDTM and ADaM standards, study protocols, statistical analysis plans, and regulatory requirements. Generate SDTM datasets from raw clinical trial data and ensure compliance with CDISC standards and company-specific conventions. Develop ADaM datasets for statistical analysis, including efficacy and safety endpoints, and generate associated TLFs. Collaborate with biostatisticians, data managers, and other team members to ensure the accuracy and integrity of clinical trial data. Perform quality control checks on SAS datasets and outputs to identify and resolve data discrepancies or inconsistencies. Generate tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions, and other project deliverables. Support ad hoc data requests and analyses from internal stakeholders, including clinical operations, medical affairs, and regulatory affairs teams. Contribute to the development and maintenance of standardized SAS macros and programming libraries to improve efficiency and consistency across projects. Stay informed about industry trends, best practices, and emerging technologies in clinical SAS programming. Key Skills: SDTM, ADaM, TLF'S, Efficacy, PK/PD, ISS/ISE Qualifications: Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field. 3-12 years of experience as a SAS programmer in the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Proficiency in SAS programming, including data step, PROC SQL, PROC REPORT, and macro programming. Experience working with SDTM and ADaM datasets, as well as familiarity with regulatory guidelines (e.g., ICH-GCP).
