13 Nov
|
Oryxion
|
Bengaluru
Company Description Oryxion is a tech-enabled data CRO that supports biotech and pharmaceutical sponsors with specialized clinical data services across the drug development lifecycle. Founded by clinical data and technology leaders with decades of CRO experience, Oryxion combines purpose-built tooling and automation with senior hands-on expertise to deliver CDISC-compliant, audit-ready outputs. The organization works through project-based engagements, FSP models, and contract staffing, serving sponsors worldwide.
Oryxion is headquartered in Bengaluru, India, with a US entity in Katy, Texas.
About the Role
We’re looking for an experienced SAS + R Programmer to join our Statistical Programming team. You’ll contribute to clinical trial programming and integrated clinical data analysis across global studies, with a strong focus on oncology efficacy and integrated summaries.
Key Responsibilities
- Develop, validate and maintain SDTM and ADaM datasets in line with current CDISC implementation guides
- Program and QC Tables, Listings and Figures (TLFs) for CSRs, interim analyses and regulatory submissions
- Lead or support efficacy programming for oncology endpoints such as OS, PFS, ORR, DoR and tumor response (RECIST)
- Program pooled datasets and outputs for Integrated Summaries of Safety (ISS) and Efficacy (ISE)
- Use R alongside SAS for analysis, validation, data visualization and reproducible workflows
- Review SAPs, mock shells and specifications, and raise data or specification issues early
- Support Define.xml, reviewer’s guides and submission-ready deliverables
- Work with biostatisticians, data managers and sponsor teams across time zones
What We’re Looking For
- 5+ years of experience in Statistical Programming in the pharma, biotech or CRO industry
- Minimum 1 year of hands-on R programming experience in a clinical setting
- Strong working knowledge of CDISC SDTM and ADaM standards and TLF programming
- Advanced SAS skills (Base SAS, SAS Macros, SAS/STAT, PROC SQL)
- Mandatory: experience in oncology clinical trials, efficacy programming, ISS/ISE, and integrated clinical data analysis
- Clear understanding of double programming and validation practices
- Positive written and verbal communication skills for working with global stakeholders
Good to Have
- Experience with R packages used in clinical reporting (e.g., admiral, tidyverse, rtables, Tplyr, ggplot2)
- Exposure to FDA/PMDA submission packages and Pinnacle 21 validation
- Experience in an FSP model working within sponsor environments
Why Join Oryxion
- Work on challenging global clinical research programs
- Be part of a senior-led biometrics team that values quality and ownership
- Grow your SAS and R skills on real submission work
📌 Senior Statistical Programming (R Programming) (Bengaluru)
🏢 Oryxion
📍 Bengaluru