Katalyst Healthcares and Life Sciences
SAS Programmer
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
Responsibilities:
You'll be at the forefront of developing and validating programs that create datasets conforming to CDISC standards. Your expertise will drive the creation of Tables, Listings, and Figures for analysis purposes. Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll also have the opportunity to mentor junior programmers and represent Statistical Programming in meetings with internal and external clients. re you prepared to integrate statistical concepts with SAS Programming efficiently and effectively. Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Independently and collaboratively resolve problems. Requirements:
Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Clearly communicate processes and standards with management and team members. Competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of. SDTM and ADaM principals. Relational Databases. Good Clinical Practice principals. Good Programming Practice principals. 21CFR Part 11 Standards principals. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.
You'll be at the forefront of developing and validating programs that create datasets conforming to CDISC standards. Your expertise will drive the creation of Tables, Listings, and Figures for analysis purposes. Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll also have the opportunity to mentor junior programmers and represent Statistical Programming in meetings with internal and external clients. re you prepared to integrate statistical concepts with SAS Programming efficiently and effectively. Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Independently and collaboratively resolve problems. Requirements:
Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Clearly communicate processes and standards with management and team members. Competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of. SDTM and ADaM principals. Relational Databases. Good Clinical Practice principals. Good Programming Practice principals. 21CFR Part 11 Standards principals. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.