Senior / Principal SAS Programmer

Epizyme   •  

Research Triangle Park, NC

5 - 7 years

Posted 237 days ago

This job is no longer available.

Key Responsibilities

  • Assess and clarify requirements, contribute to developing programming specifications, providing programming solutions and ensure their efficient implementations.
  • Provide support to the Biostatistics team in the review of the statistical analysis plan, writing of derived dataset specifications and the formatting of report documents and tabulations.
  • Implement the statistical analysis plan by the creation of SAS programs to produce tables, listings, and figures.
  • Clinical data support and non-analysis plan programming for team members outside of Biostatistics.
  • Validate, maintain, and document programs.
  • Identify system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.

Minimum Requirements

  • 5+ years in statistical programming within the Biotechnology and/or Pharmaceutical industry.
  • Strong understanding of statistical programming requirements for regulatory submissions.
  • Excellent SAS Software Programming skills, including experience with SAS/STAT, advanced DATA step, SQL and macro development to solve complex programming tasks.
  • Knowledge of SDTM and ADaM programming requirements and practices. Ability to define and implement new SDTM and ADaM domains.

Critical Skills

  • Experience with statistical analysis of oncology studies
  • Understanding of biostatistics, data management and the clinical trial process.
  • Knowledge of statistical regulatory guidance and standards (e.g., FDA, ICH and EMEA)
  • Strong knowledge of the CDISC SDTM and ADaM model

Additional Knowledge & Skills

  • Experience with relational databases.
  • Excellent written and verbal communication skills are required.
  • Excellent analytical, problem solving and organization skills
  • Ability to work independently and in ?a team environment.
  • Excellent problem solving skills.


Minimum of a Bachelor’s Degree in a computing, life science, mathematical or statistical subject.