Principal Statistical Programmer

2 days ago

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Global Channel Management, Inc.

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Description

• 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.

Requirements

• 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.