Clinical SAS Programmer (Chicopee)
Employment Type: Full-Time
Industry: Scientific Research
- This position is responsible for the creation and validation of statistical programming deliverables: compliant SDTM and ADaM datasets, and tables, figures, and listings as required for the analysis and reporting of clinical trial data. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Perform SAS programming to provide data review complex listings/reports to support Data Management function for Oncology trials.
- Design & Develop CDISC SDTM domains, SDRG & Define.xml for Oncology trials.
- Develop programs for patient profiles and ad hoc reports for data review to support the clinical teams for Oncology trials.
- Program data edit checks as necessary to facilitate Data Management's data cleaning activities.
- Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by the Oncology Data Management and other areas of Clinical for data review.
- Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.
- Ensure all programming activities and processes performed are conducted according to standard operating procedures and good programming skills.
- Good understanding of system development life cycles, GCP, and related regulatory guidelines.
Education and Experience:
- Strong SAS programming skills required in Windows and UNIX environment, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/AF/SQL.
- Extensive experience of handling external data, such as lab data, PK and of using JReview / Ireview.
- Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.
- Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, Inform, and underlying data structure is a plus.
- Knowledge of data management process, good understanding of data cleaning process.
- Strong problem-solving skills.
- SAS, (Base, Stat, Macro, graph).
- MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 5 -7 years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. SAS Certification a plus.
- Experience in SAS programming, preferably in a clinical data environment.
- Exposure of relational database structure
- Understanding of reporting systems.
- Experience with implementing standardization methodology.
- Demonstrated teamwork and interpersonal skills, strong verbal and written communication skills in a global environment.
- Ability to support study requirements with challenging timelines under direct supervision by the programming lead.
Associated topics: .net, application architect, back end, c, design, java, php, programming, senior software developer, software engineer lead
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