SDTM Programmer

South San Francisco, CA
Full-time


Position Summary:

Senior SDTM or Principal SDTM Programmer is delivery focused roles responsible for programming clinical trial analysis deliverables with quality and timeliness, following established standards and processes. This position requires technical skills and adequate industry knowledge to independently perform the programming tasks while using judgment about seeking guidance in complex situations.

Major Responsibilities:

  • Review a clinical study protocol about statistical programming responsibilities
  • Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP)
  • Review and provide input to Case Report Forms (CRFs) and external data transfer agreements
  • Work cooperatively with study team members including but not limited to the biostatistician, lead statistical programmer, data manager, and medical writer
  • Work cooperatively with and oversee a contract programming provider
  • Develop and maintain SDTM and ADaM specifications
  • Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
  • Understand and comply with MedImmune programming standards and data standards
  • Provide accurate programming time estimates to management or a study team
  • Proactively inform management of the status of statistical programming deliverables and issues
  • Meet delivery timelines for multiple concurrent studies
  • Contribute to standards or process improvements
  • Required Skills
  • Advanced SAS programming skills; competent with macro programming
  • Able to communicate clearly in oral or written form
  • Working knowledge of CDISC standards
  • Working knowledge of lab data processing
  • Working knowledge of medical terms, the data coding process, and coding dictionaries
  • Working knowledge of regulatory agency guidance

Preferred Skills:

  • Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl)
  • Working knowledge of Unix commands; able to program shell scripts
  • Advanced understanding of inferential statistics

Requirements/Qualifications:

Education: Minimum Bachelor’s Degree with a concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.

Experience: For Sr. Statistical Programmer, a minimum of 3 years of SAS programming in clinical studies and for Principal Statistical Programmer a minimum of 5 years SAS programming in clinical studies.

Supervision: Able to perform technical work independently and show good judgment about asking for guidance

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