Job Description: Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience Remote Principal Statistical Programmer requires:
- 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.
- Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
Company Description: Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best “talent ” for the job
adam spotfire Data Analyst statistics mathematics data-management sas-ods