Principal Statistical Programmer

• Minimum 3 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.

Requirements:

• Lead 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 statistical analysis plans; provide additional expertise in the analysis of clinical trials 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.