Clinical Statistical Prgmr Clinical Statistical Programmer qualified w/ Bachelor's in Pharmacy & Info Systems & 24 mths of rltd work exp as Clinical SAS Prgmr to Work collaboratively w/ Clinical Operations, Statisticians & Data Mgmt for statistical data analysis & creating CDISC package. Use knowl. of clinical trial study dsgn & electronic data submission reqmts for NDA & provide input on key study rltd docs produced by other functions (e.g. CRFs, Data Mgmt Plan, SAPs, etc.). Create SDTM & ADaM models according to CDISC stndrds, create tables, listings & graphs as well as integrated summary of safety (ISS) & integrated summary of efficacy (ISE) reports for submission to FDA. Create stndrd Macros & implmt new tools/ s/ware to minimize prgmg effort. Create macros for report generation & modifying co. designated macros for producing statistical reports & data analysis. Create, validate & approve CDISC compliant datasets, statistical analysis result, define.xml & corresponding documentation for electronic submission to regulatory agencies. Create & maintain dept. SOPs rltd to clinical prgmg. Travel to an unanticipated worksite loc. may be req'd. Mail resumes to HR Manager, Element Technologies, Inc., 15 Corporate Pl. South, Ste 209, Piscataway, NJ 08854. Job Loc: Piscataway, NJ.