Clinical SAS Programmer II

Company: Katalyst HealthCares & Life Sciences
Location: South Plainfield
Posted on: March 20, 2023

Job Description:

Job Description

Responsibilities :

• Develop statistical programming for the production or validation of analysis datasets, tabulations, graphics, and listings from clinical databases and other clinical data sources based on programming specifications and statistical analysis plans (SAPs).
• Develop specifications to define program requirements used to generate analysis datasets, tables, listings and figures. Provide support for the development of specifications and programming for operations activities such as data transfers, edit checks and trending reporting based on specifications.
• Provide technical support and propose innovative technologies for automation of operations activities.
• Write SAS programs to generate derived analysis datasets, perform analysis, validation and reporting of clinical data.
• Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
• Review and assist with maintaining existing SAS programs as needed.
• Contribute to the preparation and review of statistical analysis plans including mock table, figure and listing shells to ensure they are aligned with the CRF and study goals. Provide programming review of CRF to ensure adherence to regulatory and CDISC standards and ensure alignment with study goals.
• Establish and maintain positive relationship with the study team that fosters confidence, facilitate problem resolution, and enhance the integrity of data and deliverables.
• Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
• Work efficiently to provide high quality programming solutions that meet or exceed industry standards and regulatory requirements. Ensure that study databases and statistical programs used within the CPC comply with GCP, FDA and ICH guidelines and CPC standards.
• Effectively document and communicate requirements, timelines and progress of deliverables/projects.
• Work collaboratively with other departments at CPC to optimize cross department functionality.
• Provide weekly feedback to the supervising programmer or biostatistician on the progress of deliverables/projects. Contribute to the development and maintenance of standardized programming methods including departmental standards, global use macros and program libraries. Follow and contribute to new department and company standards in programs, datasets and directory structure.
• Assist in the development and maintenance of programming procedures and related training activities.
• Stay current on new SAS developments by regularly attending user group meetings, reading SAS related publications, taking SAS courses and/or interfacing with SAS institution personnel. Requirements:
  • A degree in a related field or SAS certificate preferred.
  • A minimum of 4 years of experience programming in SAS (v9.2+), preferably in a Windows environment.
  • A minimum of 2 years of experience working in the pharmaceutical or biotechnology industry or other regulated healthcare setting.
  • Proficiency in all basic SAS computing functionality and common data summarization and analysis strategies and procedures.
  • Demonstrable programming experience with SAS macros, ODS, Reporting, Graphics, proc SQL, and Excel.
  • Significant experience with developing and conversion of datasets to meet CDISC standards including SDTM and ADaM preferred.
  • Expertise in areas such as complex macro programming, enhanced graphics display, other programming languages e.g. R, Python is a plus.
  • Knowledge and experience with utilization of SDTM and ADaM standards, tables, listings and graphs in support of pharmaceutical product development.
  • Attention to detail, excellent organizational and team skills.
  • Demonstrated ability to work in a team environment with clinical team members.
  • Knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.

Keywords: Katalyst HealthCares & Life Sciences, New York , Clinical SAS Programmer II, Healthcare , South Plainfield, New York