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Title:Principal Statistical Programmer
Location:MA - Rockland

The SAS programmer will independently, program (or write validation programs for) and document tables/listing/graphs for clinical trials or portions of clinical trials requiring routine data manipulation and analysis. With limited direction, he/she will program (or write validation programs for) and document tables/ listings/graphs for clinical trials requiring complex data manipulation and analysis. This position will also provide input into general standardization efforts and create (or validate) global MACROs that streamline repetitive operations.

  • Mentor Biostatisticians and Statistical Programmers/Analysts with advance SAS programming techniques.
  • Interface with SAS technical support to resolve software problems.
  • Coordinate, validate and implement SAS upgrades and licenses.
  • Independently provide input into CRF specifications to collect data specified in the protocol and Query check specifications.
  • Provide input into analysis plan specifications and data presentations for clinical trials requiring complex data manipulation and analysis.
  • Independently program (or write validation programs for) patient randomizations.
  • Independently create (or validate) nonstandard or complex derived datasets.
  • Create project and study phase sub-directories ensuring that all project work resides in the correct project and study phase sub-directories.
  • Validate study phase flags in oracle tables and download study phase records from oracle tables to create analysis datasets.
  • Audit changes to the database between study phases.
  • Understand and follow all statistical and statistical programming SOPs as well as any other relevant SOP.
  • Lead process improvement teams as required.
  • Effectively communicate analysis specification and programming/data issues that arise prior to or during analysis in a timely manner.

  • MS, BS (or equivalent)
  • 8 years pharmaceutical/biotech or other relevant experience.
  • Fundamental knowledge of relevant statistical and clinical areas.
  • Expertise SAS/BASE, SAS/STAT
  • Knowledge of SAS/CONNECT, SAS/MACRO, SQL.
  • Excellent communication skills.
  • Extensive knowledge of ICH statistical and clinical report guidelines.
  • Understand the regulatory reporting and submission process and its associated time frame.

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