Senior Analyst, Statistical Programming

  • Contract
  • Remote

SimulStat

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Remote, 6-month contract

Position Summary

The Senior Analyst, Statistical Programming Consultant designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides technical expertise to the development of programming standards and procedures.

Essential Functions

  • Serves as the primary project team representative, delegating work as appropriate.
  • Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains.
  • Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
  • Reviews output across programs to ensure consistency.
  • Reviews maintains and approves study documents per standard procedures.
  • Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures.
  • Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting.
  • Participates in the development and/or maintenance of departmental procedures and standards.
  • Performs programming using techniques such as macro language, advanced data manipulation, and statistical procedures.
  • Implements data management plans designed to meet project and protocol deadlines.
  • Acts as a liaison between clinical management, subcommittees and project teams as needed.
  • May train and mentor new programmers.
  • Performs other duties as assigned.

Job Specific Qualifications

  • BS/BA degree in computer science, mathematics, statistics, or related discipline and 6+ years of experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph).
  • Demonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data
  • structures, 21 CFR Part 11, and FDA guidelines
  • Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
  • Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in
  • creating specification files for these domains.
  • Strong knowledge of writing, validating, and documenting statistical programs, and of creating
  • integrated programming libraries and systems.
  • Strong understanding of relational databases and experience working with complex data systems.
  • Experience managing projects

 

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