Clinical SAS Programmer

2 weeks ago

Plainsboro, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities :

Program analysis datasets, statistical tables, figures, and listings.
Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
Ensure quality of project programming deliverables.
Provide input on programming methodologies to support the clinical development process.

Requirements:

Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical discipline. An equivalent combination of education and applicable job experience may be considered.
Minimum of 4 years' experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
Technical knowledge and experience with SDTM, ADaM, and Define.XML.
Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
Proven experience with UNIX and Windows operating systems.
bility to effectively communicate and perform in a high demand and dynamic working environment.

Senior SAS/Statistical Programmer