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.

This listing is sourced directly from Katalysthealthcareslifesciences's careers page and normalized into a canonical job model.