Company Description Oryxion is a tech-enabled data CRO that supports biotech and pharmaceutical organizations with specialized clinical data services across the drug development lifecycle, including Clinical Data Management and EDC, Statistical Programming, Biostatistics, Medical Writing, Data Visualization, and Regulatory Affairs. The company delivers CDISC-standard, audit-ready outputs using purpose-built tools, automation, and hands-on senior expertise.

Engagement models span project-based work, functional service provider (FSP) arrangements, and contract staffing, providing flexibility for sponsors of different sizes and stages. Founded by leaders with decades of CRO experience, Oryxion operates through entities in Bengaluru, India and Katy, Texas, offering global reach with local execution.

Role Description The Senior Statistical Programmer role at Oryxion is a full time, on-site position based in Bengaluru. This role is responsible for designing, developing, and validating statistical programs to support clinical trial analysis and reporting, including SDTM and ADaM dataset creation, TFL generation, and Define.XML documentation in line with CDISC and regulatory standards.

The Senior Statistical

Programmer will collaborate closely with biostatisticians, data managers, and medical writers to ensure data integrity, accuracy, and consistency across studies and submissions. Typical responsibilities include programming and reviewing complex macros, performing quality checks and traceability reviews, troubleshooting data and code issues,



and contributing to process improvements and standardization of programming practices. The role also involves mentoring junior programmers, sharing best practices, and supporting timelines and deliverables for multiple concurrent projects.

Qualifications

- Candidates should possess strong skills in Statistical Programming and Programming, preferably with experience in SAS or similar languages used in clinical trials.
- Candidates should possess solid knowledge of Statistics and applied statistical concepts relevant to clinical research and regulatory submissions.
- Candidates should possess experience in Data Management, including working with clinical databases, CDISC standards (SDTM, ADaM), and data validation processes.
- Candidates should possess proficiency in Macro development, maintenance, and optimization to streamline programming workflows and ensure reproducibility.
- Relevant experience working within a CRO, biotech, or pharmaceutical environment, with exposure to regulatory guidelines (FDA, EMA) and ICH/GCP, is strongly preferred.
- Ability to interpret study protocols and statistical analysis plans, and to translate them into efficient, well-documented code and datasets.
- Strong analytical, problem-solving, and communication skills, with the ability to collaborate effectively in cross-functional teams and mentor junior staff.
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative field, or equivalent practical experience.

📌 Senior Statistical Programmer (Bengaluru)
🏢 Oryxion
📍 Bengaluru