NHS Human Services, Inc.

Work for a contract research organization. The job duties include: Conduct statistical analysis to determine the safety and efficacy of a drug (15%). Develop SAS programs to automatically and specifically map correlated variables in raw datasets into the SDTM datasets, which are generated from the raw datasets collected from CRFs reported by clinical sites, in accordance with CDISC standards (10%). Utilize SAS techniques (e.g., PROC SORT, MERGE, and PROC SQL) to generate and validate the inputs and the corresponding outputs in order to identify the safety and efficacy target and performance from consolidated data (10%). Develop SAS macros and programs to perform data check, including Important Protocol Deviation and prohibited medication checking; Summarize raw datasets by analyzing the safety data collected from clinical trials to ensure that all patients satisfy the requirements of corresponding clinical trials; Check whether subjects or records not meeting inclusion criteria are included in data analysis (5%). Implement statistical data analysis by reviewing the efficacy and safety objectives and endpoints and the statistical methods used from CSP and clinical SAP and apply mathematics/statistic/linear regression by utilizing SAS (e.g., PROC UNIVIRATE, PROC FREQ, PROC TTEST, PROC ANOVA) to evaluate and ensure data solidity and eliminate non-logical data (10%).  Create a reusable and efficient program for repeated jobs by using SAS MACRO (5%).  Develop the Study Data Tabulation Model (SDTM) specifications and design metadata (e.g. domain structure, variable name, variable label, derivation rule, codelist, etc.) for independent co-workers to validate the data and results (10%). Develop the Analysis Data Model (ADaM) specifications and design metadata for independent co-workers to validate the data and results, in order to derive and generate specific statistical analysis findings (e.g. analysis population flag, baseline flag, change from baseline calculation, mean questionnaire score calculation, etc.) (10%). Generate ADaM datasets from SDTM datasets or raw datasets collected from clinical sites by developing SAS programs to automatically and specifically map the correlated variables according to CDISC standards, in order to implement statistical measurement ideas and plans (e.g., two sample T-test, Chi-square test, Generalized linear regression) and prepare information for Table, Listing, and Graph outputs (10%).  Develop Tables, Listings, and Graphs for the Clinical Study Report (CSR) to present statistical analysis results from the clinical trial data based on ADaM and SDTM datasets (10%).  Implement SAS programs to generate Define-XML package for FDA submission (5%).

May work from the Fort Washington, PA, office location or may telecommute/work from a home location in the U.S.