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Urgent! SAS Programmer Job Opening In Jersey City New Jersey – Now Hiring Katalyst Healthcares & Life Sciences



Job description

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.


  • Are 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.





Required Skill Profession

Other General



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