Remote Principal Statistical Programmer at Global Channel Management, Inc.

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.