Senior Statistical Programmer

Company Description Oryxion is a tech-enabled, full-spectrum Data CRO that delivers precision clinical data services across all stages of drug development. The organization provides end-to-end support in Clinical Data Management, Statistical Programming, Biostatistics, Medical Writing, Data Visualization, and Regulatory Affairs, powered by AI-enabled analytics and integrated technology platforms. Teams at Oryxion bring extensive global experience, including hundreds of regulatory submissions to agencies such as FDA, EMA, MHRA, CDSCO, and PMDA, and deep expertise in complex trial designs and multiple therapeutic areas. The company operates across numerous EDC platforms and offers flexible engagement models including FSP, project-based delivery, and contract staffing. Oryxion maintains enterprise-grade security and regulatory compliance, with a US presence in Katy, Texas and headquarters in Bengaluru, India.

Role Description The Senior Statistical Programmer is a full-time, remote role responsible for leading the programming and validation of clinical trial datasets and outputs in accordance with CDISC standards and regulatory requirements. Day-to-day work includes developing, maintaining, and optimizing SDTM and ADaM datasets, generating TLFs, and creating robust macros and tools to improve efficiency and quality. The role involves collaborating closely with biostatisticians, data managers, medical writers, and project teams to ensure accurate, timely delivery of statistical programming deliverables. The Senior Statistical Programmer will also contribute to standards development, code reviews, documentation, and process improvement initiatives, while mentoring and guiding junior programmers. Participation in client discussions, support for regulatory submissions, and adherence to GCP and 21 CFR Part 11-compliant workflows are core aspects of this position.

Qualifications

• Strong expertise in Statistical Programming and Programming within clinical trials, including CDISC standards (SDTM, ADaM) and TLF generation.
• Solid foundation in Statistics, with the ability to understand and implement statistical analysis plans and contribute to methodological discussions.
• Proficiency in macro development (e.g., SAS macros or equivalent) to automate workflows, enhance reproducibility, and support standardization.
• Bachelor's or Master's degree in statistics, biostatistics, computer science, mathematics, life sciences, or a related quantitative field.
• Experience in clinical research or a CRO environment, supporting global regulatory submissions across multiple regions and agencies.
• Familiarity with ICH-GCP, 21 CFR Part 11, and relevant industry guidelines; experience with multiple EDC/clinical platforms is an asset.
• Strong analytical, problem-solving, and documentation skills, with the ability to work