Clinical Statistical Programmer

Clinical Statistical Programmer

qualified w/bachelor's in biotechnology or pharmacy & 60 mos of rltd work exp 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 accord to CDISC stds, create tables, listings & graphs as well as integrated summary of safety (ISS) & integrated summary of efficacy (ISE) reports for submission to FDA. Create std 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. Occasional travel to unanticipated client-site locs w/in USA may be reqd as a roving employee. Annual Salary is $110,822.00 per annum. Aspiring candidates should mail their resumes to HR Mgr, Element Technologies, Inc. 1100 Cornwall Rd, Ste 113, Monmouth Junction, NJ 08852. Job Loc: Monmouth Junction, NJ 08852.