Katalysthealthcareslifesciences
Clinical SAS Programmer
Newark, NJ, United States · Junior
Sponsorship not specifiedDetected 363 days ago
StatisticsClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceSASResearchCommunicationProblem SolvingBiostatistics
About the role
- All your information will be kept confidential according to EEO guidelines.
Responsibilities
- Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
- Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets.
- Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
- Provides input in the design and development of case report forms and clinical databases.
- Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
- Provides input in the design and development of case report forms and clinical study databases.
Requirements
- MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
- Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Familiarity with FDA and ICH regulations and guidelines.
- Ability to prioritize and multi-task effectively.
- Demonstrated positive attitude and the ability to work well with others.
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