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Principal Statistical Programmer

Principal Statistical Programmer

Katalyst HealthCares & Life SciencesPhoenix, AR
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Responsibilities :

  • Ensure departmental or functional training plans in place and appropriate.
  • Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget.
  • Generate, validate, and / or review SDTM domains and ADaM datasets and associated specifications.
  • Generate, validate, and / or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
  • Generate or perform quality control for SAS programs and other study documents (, presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
  • Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
  • Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Develop and / or maintain departmental procedures and standards.
  • Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
  • Manage, generate, and / or review , , , and reviewer's guide documents.
  • Assist in validation of SAS per CFR Part .

Requirements :

  • Bachelor's degree in Statistics, Mathematics, Computer Science or a related field required.
  • Minimum of years biotechnology / pharmaceutical / CRO industry experience as a statistical programmer.
  • Prior experience overseeing statistical programming contractors required.
  • Compound oversight experience highly preferred.
  • Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS / STAT, SAS / Graph, SAS / SQL and SAS / ODS.
  • Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards / implementation guides, CFR Part , and FDA guidelines.
  • eCTD NDA submission experience is a must.
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    Programmer • Phoenix, AR