SKILL BUDDY INC

Sr. Statistical Programmer, Master’s degree in Information Technology Management, Computer Information Systems with 2 years; Create and validate SDTM & ADaM datasets in compliance with published industry standards & project/study specific requirements; Liaise with Data Management, Biostatistics for database, dataset specifications, timelines, and quality requirements; Work with CDISC CDASH, SDTM, ADaM, DEFINE.XML, and/or controlled terminology; Implement standard data solutions from CRF design through data analysis and reporting; Create & validate tables, listings, and graphs (TLGs) as well as statistical documents for Clinical Study Report (CSRs), Integrated Summary of Safety (ISS), & Integrated Summary of Efficacy (ISE) as per Statistical Analysis Plan (SAP); Direct & mentor Programmers/Analysts to enforce appropriate standards for NDA submission related to ISS/ISE, POP PK analysis & provide training to team regarding clinical data submission, Pinnacle 21; Create macro libraries, format catalogs, visual output displays, training presentation & documentation that can help drive programming efficiencies across studies & projects.

 

Skills: SDTM, ADaM, CDISC CDASH, .XML, ISS, ISE & Pinnacle 21.  

 

Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting.

 

Send Resume to Skill Buddy Inc, 1135 Kildaire Farm Road, Suite # 200,  Cary,  NC, 27511.