Remote Principal Statistical Programmer
About the job 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:
ā¢ Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
ā¢ FDA submission experience is highly desirable.
ā¢ Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
ā¢ Ability to use professional concepts to achieve objectives in creative and effective ways.
ā¢ Experienced in managing multiple projects.
ā¢ Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
ā¢ Solid knowledge of other software such as SpotFire, R Shiny etc. is a plus.
ā¢ BS/MS in Statistics, Math or Scientific Discipline.
Remote Principal Statistical Programmer duties:
ā¢ Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
ā¢ Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
ā¢ 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.
ā¢ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
ā¢ Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
ā¢ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.
Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
Remote Principal Statistical Programmer requires:
ā¢ Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
ā¢ FDA submission experience is highly desirable.
ā¢ Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
ā¢ Ability to use professional concepts to achieve objectives in creative and effective ways.
ā¢ Experienced in managing multiple projects.
ā¢ Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
ā¢ Solid knowledge of other software such as SpotFire, R Shiny etc. is a plus.
ā¢ BS/MS in Statistics, Math or Scientific Discipline.
Remote Principal Statistical Programmer duties:
ā¢ Lead on clinical studies and integrated analyses and provide guidance and training to other lower level personnel.
ā¢ Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
ā¢ 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.
ā¢ Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
ā¢ Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP).
ā¢ Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.