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Senior Clinical Programmer Analyst

Integrated Resources, Inc

This is a Contract position in Woodcliff Lake, NJ posted December 16, 2019.

Job Title: Senior Clinical Programmer Analyst Location: Woodcliff Lake, NJ 07677 Duration: 12 months Contract JOB DESCRIPTION Performs SAS programming to provide complex data review listings/reports to support different functional groups for Oncology trials.

Program data review checks as necessary to facilitate data cleaning activities.

Design standard programs and macros using study metadata.

Design and develop SAS macros, applications, and other tools to expedite SAS programming activities to support different areas of Clinical data review.

Develop standard SAS utility macros for developing standard programs.

Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.

Ensure all programming activities and processes are performed following standard operating procedures and good programming practices.

Participate in system validation, customization, and integration of new tools and technologies.

Qualification: Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/SQL.

Experience in writing SAS tools and developing generic SAS programs for clinical studies Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide, SAS Data Integration Studio, SAS Studio is a plus Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, InForm, and underlying data structure is desirable.

Additional experience: Good understanding of system development life cycles, GCP, and related regulatory guidelines.

7-10 years of experience in programming with clinical trial data and preparing programming and test documentation.

Experience with all clinical phases I, II, III and IV of oncology trails is desirable.

Good understanding of Recist, mRecist, irRecist and Rano criteria.

Extensive experience of handling external data, such as lab data, PK, Tumor, Biomarker, Imaging etc.

Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.

Good understanding of Regulatory requirements for submissions to FDA, PMDA and EMA.

Strong problem solving skills Able to work independently and a team player, good organizational and time management skills.

Excellent communication skills & capable of communicating technical concepts Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.