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Open nowFirst seen 2 days ago

Remote Principal Statistical Programmer

global-channel-management-inc944 open roles

Where
Cambridge, MA, United States, Remote
Work mode
Remote
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Your applicationOpen nowRemote Principal Statistical Programmerglobal-channel-management-inc · Cambridge, MA, United States, Remote

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Share of postings closed within
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  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.5%14 days
  5. 35.5%30 days
  6. 45.1%60 days
This job: first seen 2 days ago

The posting

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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