Senior Clinical Programmer Analyst
Woodcliff Lake, NJ Posted: 12/6/2019
We have multiple needs for Senior Clinical Programming Analysts with a leading Pharmaceutical Company in NJ. We look forward to reviewing your application!
- Perform 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.
- 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.
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