Senior Programmer Submission

Added
23 days ago
Type
Full time
Salary
Salary not provided

Related skills

r sas cdisc regulatory submissions sdtm

๐Ÿ“‹ Description

  • Program and validate clinical datasets and SDTMs, including complex efficacy and laboratory data.
  • Develop complex non-efficacy outputs, tables, figures, and statistical deliverables.
  • Lead programming teams across multiple studies, ensuring quality and timely delivery.
  • Review study designs and Statistical Analysis Plans independently, provide technical feedback.
  • Support regulatory submissions including CDISC requirements and define.xml/pdf documentation.
  • Promote programming best practices and ensure adherence to SOPs and quality checklists.

๐ŸŽฏ Requirements

  • Bachelor's degree or higher in CS, Math, or related field.
  • 5+ years SAS programming in pharma/CRO industry (essential).
  • 5+ years experience with CDISC standards, SDTM and ADaM.
  • Strong practical experience with Pinnacle 21 for data validation.
  • Experience with ISS, regulatory submissions, or BIMO activities.
  • Proficient in R programming (preferred).

๐ŸŽ Benefits

  • Flexible working arrangements: remote work available anywhere in India.
  • Flexible hours: part-time working hours may be available.
  • Training and development: structured training plans and skill development.
  • Continuous learning: opportunities in clinical programming and data science.
  • Supportive working environment: collaborative and quality-focused culture.
  • Work-life balance: emphasis on maintaining healthy balance.
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