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. Originally posted on Himalayas