SAS Programmer

Position Overview We are seeking an experienced SAS Programmer - Pharmaceutical to join our clinical programming team. The successful candidate will be responsible for developing, testing, and maintaining SAS programs for clinical trial data processing, CDISC dataset creation, and regulatory submission deliverables in compliance with pharmaceutical industry standards. Key ResponsibilitiesSAS Programming & Development Develop and maintain complex SAS programs for clinical trial data processing and transformation Create SDTM (Study Data Tabulation Model) datasets from raw clinical data Build ADaM (Analysis Data Model) datasets for statistical analysis Generate tables, listings, and figures (TLFs) using SAS procedures Develop reusable SAS macros and standard programming libraries Optimize SAS code for performance and efficiency Data Processing & Validation Transform and clean clinical trial data using SAS DATA steps and procedures Implement data validation checks and quality control processes Create and maintain data derivation specifications and programming documentation Perform dataset reconciliation and data integrity checks Debug and troubleshoot SAS programs to ensure accurate outputs CDISC Implementation Implement CDISC standards (SDTM, ADaM) using SAS programming Create and maintain CDISC-compliant datasets for regulatory submissions Develop define.xml files and associated documentation Ensure metadata consistency across programming deliverables Support CDISC validation and compliance reviews Regulatory Support Prepare SAS programs and datasets for regulatory submissions (NDA, BLA, IND) Ensure programming deliverables meet FDA, EMA, and other regulatory requirements Support regulatory inspections by providing programming documentation Maintain 21 CFR Part 11 compliance in all programming activities Create and maintain programming specifications and validation documentation Technical Collaboration Work with biostatisticians to understand analysis requirements and specifications Collaborate with data managers on database design and data transfer processes Support clinical teams with ad-hoc programming requests and data queries Participate in UAT (User Acceptance Testing) and validation activities Provide technical guidance to junior programmers Required QualificationsTechnical Skills Advanced proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro) Strong experience with SAS DATA steps, procedures, and functions Proficiency in SQL and database programming Experience with CDISC standards implementation (SDTM, ADaM) Knowledge of clinical trial data structures and pharmaceutical data flows Understanding of regulatory requirements for pharmaceutical submissions Experience Bachelor's degree in Computer Science, Statistics, Mathematics, or related field 3-5 years of SAS programming experience in pharmaceutical/biotech environment Hands-on experience with clinical trial programming and CDISC datasets Experience with regulatory submission programming deliverables Knowledge of clinical research processes and Good Clinical Practice (GCP) Programming Competencies Expertise in SAS macro programming and automation Experience with complex data manipulations and transformations Proficiency in creating and maintaining programming documentation Strong debugging and troubleshooting skills Experience with version control systems and programming best practices Preferred QualificationsAdvanced Technical Skills Experience with SAS Enterprise Guide, SAS Studio, or SAS Viya Knowledge of other programming languages (R, Python, SQL) Experience with cloud-based SAS environments (AWS, Azure) Familiarity with clinical data standards beyond CDISC (HL7 FHIR, etc.) Experience with automated testing and validation frameworks Industry Experience Experience across multiple therapeutic areas and study phases Knowledge of adaptive trial designs and complex study protocols Experience with global regulatory submissions and requirements Familiarity with electronic submission formats (eCTD, STDM) Experience with clinical trial management systems and EDC platforms Certifications SAS Certified Base Programmer SAS Certified Advanced Programmer CDISC certification (preferred) Technical EnvironmentSAS 9.4 or SAS Viya platform Windows/Linux server environments Oracle, SQL Server, or other enterprise databases Version control systems (Git, SVN) Clinical trial management and EDC systems Working ConditionsHybrid/remote work flexibility Collaborative programming team environment Project-based work with varying deadlines Occasional overtime during submission timelines Professional development and training opportunities