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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