Statistical Programmer II - PRO
India, Remote 职位编号 R0000033964 类别 Statistical Programming关于这个职位
This role supports the generation of evidence from patient-reported outcomes across multiple therapeutic areas, with a strong emphasis on oncology. The ideal candidate will have hands-on experience with clinical trial data, deep familiarity with PRO instruments, and strong SAS programming skills. Knowledge of CDARS and experience working in a global, cross-functional environment are essential.
Key Responsibilities
- Develop, validate, and maintain SAS programs for PRO data analysis, including derivation of endpoints, generation of TLFs, and QC of outputs
- Collaborate with statisticians, study leads, and cross-functional teams to interpret protocols and SAPs, define specifications, and deliver high-quality outputs
- Support the development and maintenance of standard templates and macros for common PRO instruments (e.g., EQ-5D, EORTC QLQ-C30, FACT-G)
- Participate in the creation and refinement of guidance documents, SOPs, and training materials for PRO programming workflows
- Ensure compliance with internal quality standards and regulatory expectations, including documentation of programming logic and QC processes
- Engage in biweekly PRO team meetings to share updates, troubleshoot issues, and align on priorities
Required Qualifications
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, or a related field
- 3–5 years of experience in statistical programming with a focus on clinical trial data and PRO endpoints
- Proficiency in SAS; working knowledge of R is a plus
- Strong understanding of CDARS and familiarity with CDISC standards
- Experience with multiple therapeutic areas; oncology experience is highly preferred
- Ability to work independently and collaboratively across time zones in a multicultural environment
Preferred Qualifications
- Familiarity with regulatory guidance on PROs and clinical outcome assessments
- Experience with automation tools and version control systems (e.g., Git)
- Exposure to project management tools like Monday.com
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