The Statistical Programmer is responsible for providing significant programming support to the statisticians as part of the contribution towards the completion of statistical analyses (tables, listings and figures) and reporting of results of clinical studies.
It includes Safety, Immunogenecity and Efficacy Analysis. In addition, other ad hoc analysis may have to be performed, based on the need, such as, analysis for Annual Reports, Publications, Information Brochure, Sales Aids, Poster Presentations, VRBPAC, CR and IR letters from regulatory agencies such as FDA, Drug Safety Monitoring Board (DSMB), exploratory analysis and other miscellaneous analysis as required by project/study teams. Assist in developing/building new tools or applications, developing and implementing new standards.
Knowledge of SAS software, including macros programs development, and awareness of current features in SAS, especially in Base SAS, SAS/Stat and SAS/Graph.
Knowledge of additional programming languages, such as, C ++, R, Python, Visual Basic, Oracle, etc., would be a plus. Aptitude for "Look and feel for software" would be desirable.
Requires excellent programming skills, experience with regulatory submission (NDA, eBLA/BLA, CTD/eCTD), and the ability to work in a multidisciplinary team.
***3-9 years of pharma or vaccine experience
M.S in Statistics, Biostatistics, Mathematics or a related field
Source: Job Diva – Job Listing