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SAS Programmer
SAS ProgrammerKatalyst HealthCares & Life Sciences • Jersey, NJ
SAS Programmer

SAS Programmer

Katalyst HealthCares & Life Sciences • Jersey, NJ
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.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.
  • CFR Part Standards principals.
  • Integrated Summary Safety / Efficacy Analyses.
  • Safety data and Coding Dictionaries (MedDRA and WHODD).
  • ICH eCTD format.
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