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Support in review of the Statistical analysis Plan/shells.
Program and validate final statistical analyses for safety.
Support developing the shells for a statistical analysis document.
Program and validate final statistical analyses.
Standard Macros and SOP
Develop re-usable code or MACROS using SAS for all the safety analyses.
Support in developing standard efficacy analyses and graphs (e.g. KM curves) using a reusable Macro.
Develop a MACRO to generate patient profiles, including addition of customization to get specific data from specific patients.
Review an SOP for validation of standard analyses related outputs and re-usable programs.
For each study generate permanent safety analysis data sets.
Validate safety related outputs at the time of delivery deadlines.
Support standard Safety analyses related tables/listings shells.
Programming support to data management to detect database issues and cleanup and provide reports to aid data review.
Assist in developing a regulatory compliant project management system.
Bachelor's degree in Math/stats/computer science; Master's in statistics preferred; or equivalent industry experience.
2-4 years of SAS programming experience in the pharmaceutical, biotechnology, and/or cSome experience in programming in Oncology area desirable.ontract research organization industries.
Some experience in programming in Oncology area desirable.
Extensive knowledge of Base SAS, SAS/GRAPH, SAS/STAT, SAS/MACRO and ODS.
Ability to work independently and adept at managing multiple competing tasks.
Good understanding of clinical data and pharmaceutical development.
Knowledge of SDTM, ADaM, FDA and ICH guidance.
Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials.
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