Clinical SAS Programmer

Katalyst Healthcares & Life Sciences Inc
Full Time
Hayward, CA 94541
Posted
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Job description

Responsibilities:

  • Supports statistical programming activities for clinical studies, submissions, and development initiatives.
  • Contributes to timelines and work product required to deliver high quality statistical programming services.
  • Maintains a basic understanding of relevant industry trends in standards implementation and clinical statistical programming.
  • Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics.
  • Supports collaboration with Data Management on database standards to facilitate SDTM development.
  • Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are validated and meet standards requirements of regulatory agencies, Sponsors, and Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools.
  • Develops specification documents for all datasets, and other supporting documents such as define.xml, annotated CRFs, and reviewer’s guides.
  • Programs, validates, maintains, and documents statistical analysis programs for deliverables outlined in the statistical analysis operating procedures.

Requirements

  • A BA/BS degree or equivalent in a relevant scientific discipline.
  • A minimum of 5 years of experience supporting clinical trials for regulatory submissions with sufficient experience leading statistical programming activities.
  • A high level of SAS programming skills including SQL and macro development.
  • Good knowledge and application of CDISC standards for SDTM and ADaM.
  • Experience with Pinnacle21 and writing reviewer’s guides is a plus.
  • Basic understanding of standard statistical methodologies is expected.
  • Experience with ophthalmology is preferred.

Job Type: Contract

Experience level:

  • 5 years

Schedule:

  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Hayward, CA 94541: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • Informatica: 1 year (Preferred)
  • SQL: 1 year (Preferred)
  • Data warehouse: 1 year (Preferred)

Work Location: In person

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