SAS Clinical Trails Programmer - Katalyst Healthcares and Life Sciences : Job Details

SAS Clinical Trails Programmer

Katalyst Healthcares and Life Sciences

Job Location : Cary,NC, USA

Posted on : 2025-08-05T07:49:16Z

Job Description :
Responsibilities:
  • The consultant will provide programming/analytical support utilizing client as the primary programming language to create and manage the production of analysis reports.
  • summary tables/listings and graphs for clinical trials submitted to various regulatory bodies worldwide.
  • The consultant must have excellent communication skills and must be able to communicate about the techniques developed and results of analysis both to executives and other analysts in the organization.
  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming.
  • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
  • Develop SAS programs and generate complete, accurate and validated statistical TLGs in well-defined formats.
  • Program SDTM and ADaM datasets according to the dataset specifications
  • Create SDTM annotated patient Case Report Forms.
  • Perform data conversion between datasets with two different formats according to conversion requirements/specifications, e.g., converting from Excel data records to client datasets, non-CDISC compliant datasets to CDISC compliant datasets.
  • Manage electronic data transfers from trial sponsors or other external clinical trial data vendors, such as central laboratories or other specialty laboratories.
  • Document data and programming information in accordance with Corporate Governing Documents (Policies, SOPs, or Work Instructions).
  • Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with Corporate Governing Documents and/or clinical trial sponsor's specific requirements.
  • Write SAS programs to produce tables, listings, and graphs for ad hoc requests, annual progress reports, integrated summaries, publications and other clinical research reports.
  • Collaborate with Biostatisticians, Clinical Research Associates, Medical Writers, Regulatory Affairs and Clinical Data Management teams to gather specifications for informative tables, listings and graphs.
  • Build client data sets from various data sources which meet provided specifications.
  • Execute edit/logic checks to assist in data cleaning.
  • Maintain and execute programs for the evaluation and validation of incoming clinical data.
  • Perform validation of the analysis data sets, tables, listings and graphs.
  • Utilize macro libraries and complex data step techniques to standardize programming.
  • Maintain and enhance existing programs for clinical studies.
  • Gather and analyze programming requirements to develop clinical trial reporting systems.
  • Maintain detailed design specifications.
  • Ensure that programs and reports follow departmental/company standard operating procedures.
  • Assist in the development of departmental systems and generate/maintain systems documentation.
  • Participate in the preparation of clinical and statistical summary reports.
Requirements:
  • Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Healthcare or technology related field.
  • 6+ years of SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry.
  • Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
  • Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
  • CDISC data models a necessity, especially SDTM then ADaM.
  • SDTM and ADaM dataset experience.
  • Good written and spoken communications skills in English and thought-leadership skills.
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