SKILL BUDDY INC

Senior Statistical Programmer, Bachelor’s degree in Pharmaceutical Sciences, Pharmacy with 5 years of experience in job title with similar duties and skills; Involve in transformation of clinical trial raw data into a standardized SDTM format that facilitates regulatory submissions. Prepare and submit annotated CRF, Develop and validate SDTM data specifications and datasets (e.g.
DM, SV, LB, TS, TR) using SAS programming by following Study Data Tabulation Model (SDTM) Implementation Guide (IG) version 3.2, 3.3, 3.4 and ensuring compliance with regulatory standards; Develop analysis-ready specifications (ADaM) and datasets like ADSL, ADAE, ADCM, ADLB, pharmacokinetic concentration (ADPC) and pharmacokinetic parameters (ADPP) analyses etc from clinical trial data by following study Statistical Analysis Plan (SAP) and Analysis Data Model (ADaM) Implementation guide version 1.1, 1.2 developed by Clinical Data Interchange Standards Consortium (CDISC).

 

Skills: SDTM, SAS programming, ADaM, CDISC and SAP.

 

Must be willing to travel and/or relocate to work in various worksites throughout the US. No telecommuting.

 

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