Clinical SAS Programmer

5 days ago

Austin, TX, United States Katalyst Healthcares and Life Sciences Full time
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.
  • Programs quality checks for clinical study raw data and report the findings to Data Management.
  • Provides input in the design and development of case report forms and clinical study databases.
  • Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming.
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.
  • Experience in providing statistical programming support to early and late phase clinical trials.
  • Excellent skills in SAS programming and statistical reporting.
  • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
  • Familiarity with FDA and ICH regulations and guidelines.
  • Excellent problem-solving skills.
  • Good written and verbal communication skills and organizational and documentation skills.
  • bility to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
  • bility to prioritize and multi-task effectively.
  • Demonstrated positive attitude and the ability to work well with others.

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