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Principal Statistical Programmer
Principal Statistical ProgrammerKatalyst HealthCares & Life Sciences • Hartford, CT
Principal Statistical Programmer

Principal Statistical Programmer

Katalyst HealthCares & Life Sciences • Hartford, CT
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.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, CFR part , 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 + 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 and experience with Pinnacle 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.
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    Principal Statistical Programmer • Hartford, CT

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