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Statistical Programmer
Statistical ProgrammerKatalyst HealthCares & Life Sciences • Irvine, CA
Statistical Programmer

Statistical Programmer

Katalyst HealthCares & Life Sciences • Irvine, CA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Responsibilities :

  • This person will be responsible for development and generation of analysis datasets, tables, listings, and graphs from assigned clinical sources using SAS and / or R; leading development and maintenance of associated operating procedures; and participating in external industry forums (, CDISC, SDTM, and relevant User Groups).
  • This individual performs with minimal guidance on moderately difficult deliverables.
  • Utilize programming standards to develop efficient and accurate programs using SAS and / or R.
  • Support creating and / or maintaining Programming Infrastructure in SAS and / or R.
  • Support in developing and maintaining R scripts for data analysis, statistical modelling, and visualization is a plus.
  • Keeping up to date with the latest R packages, techniques, and best practices is desirable.
  • Work with Data Management leadership to provide input on reporting processes and standards.
  • Support programming deliverables for clinical trials and support for any custom Data Management reports.
  • Participate in the development and maintenance of global harmonized processes and procedures for programming.
  • Provide quality programming deliverables.
  • Facilitate the delivery of standard metric reports.
  • Ability to design, implement and maintain moderately complex programming deliverables across a wide variety of clinical platforms and thereputic areas.
  • Conduct independent QC programming and peer review of code and deliverables.
  • Demonstrated ability work in teams to deliver critical milestones.
  • Connect – Participate in strategic partnerships with Clinical and Biostatistics functions at the Enterprise level to ensure MD programming practices meet the needs of the organization.
  • Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define / refine SDTM standards.
  • Lead – Present opportunities in programming practices that increase quality of deliverables.
  • Deliver – ensure high quality programming deliverables for clinical programs are delivered on time and in compliance to regulations and SOPs, seamlessly across all Franchises.

Requirements :

  • A bachelor's degree in Statistics, Computer Science or related discipline (required).
  • Minimum years of system support in clinical research within Medical Device or Pharmaceuticals.
  • Proficiency in Base SAS, SAS / STAT and SAS Macro language.
  • Strong debugging, problem-solving, and documentation skills.
  • Excellent verbal and written communication skills.
  • Support the maintenance of established SAS platform.
  • Support the maintenance of a global SAS macro library.
  • Work with Clinical Data Science (CDS) partners, and leadership in Clinical Operations and Franchise to set implement plans for timely delivery of reports, metrics, and study deliverables.
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