Company:
Katalyst Healthcares & Life Sciences
Location: Cincinnati
Closing Date: 04/12/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities.
Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with statisticians and other clinical team members to ensure programming requirements are understood.
Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
Managing/coordinating resources on study basis to ensure high-quality and on-time deliverables of statistical analyses.
Capable of developing the written specifications based on SDTM/ADaM Implementation Guide and creating programs to produce CDISC-compliant SDTM/ADaM datasets and define.xml files.
Generate tables, figures, and listings, (TFLs) in accordance with TFL shells to support analyses using.
Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
Capable of validating SAS programs, macros, datasets, and TFL output generated by other programmers.
Requirements:
Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required.
BA/BS degree and a minimum of 4 years of related.
Advanced degree preferred.
High proficiency in SAS programming and Macro development.
Experience working with CDISC SDTM and ADaM compliant data sets.
Experience with regulatory submissions.
Experience programming supporting integrated analyses, e.g. ISS, Client.
Good Knowledge of statistics and the drug development process.
In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices.
Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
Responsibilities.
Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with statisticians and other clinical team members to ensure programming requirements are understood.
Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
Managing/coordinating resources on study basis to ensure high-quality and on-time deliverables of statistical analyses.
Capable of developing the written specifications based on SDTM/ADaM Implementation Guide and creating programs to produce CDISC-compliant SDTM/ADaM datasets and define.xml files.
Generate tables, figures, and listings, (TFLs) in accordance with TFL shells to support analyses using.
Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
Capable of validating SAS programs, macros, datasets, and TFL output generated by other programmers.
Requirements:
Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required.
BA/BS degree and a minimum of 4 years of related.
Advanced degree preferred.
High proficiency in SAS programming and Macro development.
Experience working with CDISC SDTM and ADaM compliant data sets.
Experience with regulatory submissions.
Experience programming supporting integrated analyses, e.g. ISS, Client.
Good Knowledge of statistics and the drug development process.
In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices.
Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
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