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Statistical Programmer II - PRO

India, Remote 职位编号 R0000033964 类别 Statistical Programming
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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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