Senior Statistical Programmer

  • Contract
  • Remote

SimulStat

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Remote, 12-month initial contract with potential to extend long term

Senior Statistical Programmer
 
Essential functions
 

  • Develop or review and QC CDISC-compliant datasets (SDTM & ADaM) and corresponding documentation for electronic submission.
  • Develop SAS programs to generate or QC displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies, internal deliverables, and publications.
  • Ability to write new SAS macros or incorporate existing SAS macros into individual programs.
  • Review and provide input on key study-related documents (e.g., CRFs, SAPs, etc.)
  • Review and remain compliant with SOPs and Technical Guide documents related to Statistical Programming.
  • Review and update documentation for tracking programming assignments and progress.
  • Review, update, provide input and follow programming plans.
  • Provide time and resource estimates for programming assignments and project planning.
  • Assist statisticians, clinicians & other study-team members by suggesting algorithms and data displays to address novel analysis or data review requests.

 
Desired knowledge, skills, and abilities
 

  • Skilled programming with SAS programs and macros. Knowledge of additional programming languages like R or Python is a plus.
  • At least 10 years of experience working on CDISC standards (including SDTM and ADaM models), Tables, Listings and Figures.
  • In-depth knowledge of clinical statistics and drug development process.
  • Experience as lead programmer at study and/or molecule level.
  • Solid verbal and written communication skills.

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