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Urgent! Principal Statistical Programmer Job Opening In Atlanta Georgia – Now Hiring Katalyst Healthcares & Life Sciences

Principal Statistical Programmer



Job description

Responsibilities:


  • Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.


  • Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.


  • Following specifications, develops algorithms and writes programs to create datasets.


  • Produces data listings, summary tables and graphs using SAS software.


  • Independently check data listings, summary tables and graphs.


  • Imports and exports SAS data.


  • Assists data management group in performing data edit checks.


  • Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.


  • Plays an active role in taking project solutions and generalizing them for the Biostatistics group.


  • Interact with the project statistician and guides other programmers participating on a project team.


  • Experience with Pooled analysis, regulatory agencies requirements and e-submission experience.




Requirements:




  • Minimum of 10+ years of statistical programming experience in the life science industry and relevant bachelor's degree

  • Must have recent NDA submissions experience.


  • ISS/Client safety & efficacy experience is required.


  • Experience creating define.xml and experience with Pinnacle 21 and specifications.


  • SAS Certified Base and/or Advance Programmer experience is preferred.


  • Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.


  • Experience with SDTM and ADaM industry data standards.


  • Good communication skills and attention to detail are crucial.


  • Proven ability to handle multiple tasks.


  • Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.




Required Skill Profession

Other General



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