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Remote Principal Statistical Programmer

Global Channel Management
Cambridge, MA Remote Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/8/2025

About the job Remote Principal Statistical Programmer

Remote Principal Statistical Programmer needs 10 years Pharmaceutical / Biotech programming experience including macro / tools development experience.

Remote Principal Statistical Programmer requires :

  • Minimum 10 years Pharmaceutical / Biotech programming experience including macro / tools development experience.
  • FDA submission experience is highly desirable.
  • Strong SAS programming and Statistical background with strong skills in SAS Base, SAS / Macros, SAS / Graph and SAS / Stat.
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experienced in managing multiple projects.
  • Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
  • Solid knowledge of other software such as SpotFire, R Shiny etc. is a plus.
  • BS / MS in Statistics, Math or Scientific Discipline.

Remote Principal Statistical Programmer duties :

  • Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
  • Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
  • Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
  • Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
  • Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
  • Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.

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