Sr. Statistical Programmer

1 day ago


Newark, NJ, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
  • Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
  • Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
  • Development and review CDISC SDTM and ADaM mapping specifications.
  • Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
  • Review datasets for any pending compliance issues and meticulously document identified issues.
  • Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
  • Generation of utility macros and efficient code writing to streamline programming processes.
  • Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
Requirements:
  • Master's degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 4 years of SAS programming experience. Alternatively, a bachelor's degree with at least 6 years of SAS programming experience.
  • minimum of 2 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.
  • Proficiency in SAS Programming.
  • Previous involvement as a production or QC programmer at both product and study levels.
  • Strong organizational, interpersonal, leadership, and communication skills.
  • bility to autonomously manage multiple tasks and projects.
  • In-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
  • minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.


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