SAS Programmer

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.

• 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.
• CFR Part Standards principals.
  
  Integrated Summary Safety/Efficacy Analyses.
• Safety data and Coding Dictionaries (MedDRA and WHODD).
• ICH eCTD format.