#977 - STATISTICAL PROGRAMMER II

Job Opportunity only available for professionals located in Latin America . We're seeking an experienced Statistical Programmer II to support clinical development programs within the Biometrics organization. This role is intended for a programmer with 2–3 years of pharmaceutical industry experience who can independently deliver high-quality, compliant, and submission-ready statistical programming deliverables across clinical trials. The Statistical Programmer II will work closely with biostatisticians, data management, and cross-functional partners to ensure accurate implementation of analysis specifications and regulatory standards, contributing directly to clinical trial analyses, regulatory submissions, and inspection readiness. Requirements: • Advanced English level (B2/C1/C2) to ensure fluent communication with customers and teams. • 2–3 years of statistical programming experience within a pharmaceutical, biotechnology, or clinical research organization. • Strong hands-on experience with SAS for clinical trial programming; working knowledge of R preferred. • Solid understanding of clinical trial data structures and end-to-end development processes. • Working knowledge of CDISC standards , including ADaM; familiarity with SDTM required. • Understanding of regulatory expectations for statistical programming, including documentation, traceability, and inspection readiness. • Demonstrated ability to manage multiple deliverables independently while meeting timelines and quality expectations. • Strong analytical, problem-solving, and troubleshooting skills. • Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams. • High attention to detail, strong documentation practices, and commitment to quality and compliance. Responsibilities: • Independently develop, validate, and maintain analysis-ready datasets in accordance with approved specifications, including: • ADaM datasets • Supporting analysis datasets required by the SAP • Program, generate, and validate Tables, Listings, and Figures (TLFs) using SAS, ensuring alignment with approved SAPs, shells, and programming standards • Perform independent QC and peer review of datasets and outputs to ensure accuracy, traceability, and reproducibility • Implement and enforce CDISC standards , including SDTM (as applicable) and ADaM, across assigned studies • Collaborate closely with Biostatistics to translate SAP requirements into robust and efficient programming solutions • Partner with Data Management to resolve data issues and ensure consistency between SDTM and ADaM datasets • Support ongoing data review, including identification of data trends, anomalies, and potential risks to analysis integrity • Ensure all programming deliverables are submission-ready and inspection-ready , in compliance with internal SOPs and global regulatory expectations • Support preparation and delivery of programming components for regulatory submissions (e.g., NDA, BLA, MAA) • Maintain complete and compliant programming documentation , including specifications, program headers, and QC records • Contribute to the development and optimization of programming standards, macros, and reusable code • May provide informal guidance or technical support to junior statistical programmers What do we offer? • 100% Remote work. • Competitive salary in USD. • Type of contract: Independent Contractor with Venon Solutions LLC. • Contract duration: Long-term. • 2 weeks of PTO (paid time off). • Paid Holidays: from the Client's calendar (USA) • Working hours: Full-time EST timezone , fully committed.