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Title:Sr. Statistical Programmers
Salary:$90-120K+ (Contract:$75-90/hr)
Experience:5+
Location:MA - Lexington

Description:
With minimal supervision, programs, tests and documents SAS programs which create tables, listings and figures for the summarization of clinical trial data, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

Responsibilities:
  • Assist in the preparation of the regulatory submission-ready packages
  • Assist in creating specifications for the integration of data from multiple studies
  • Conduct programming and documentation for integrated summaries and regulatory submissions
  • May serve as the statistical programming function lead on clinical project teams
  • Contribute to SOP development and process improvement efforts
  • May mentor/train other team members in departmental procedures and developing technical expertise
  • Follow good programming practices and adequately document programs
  • Create and maintain file structures for storing clinical data
  • Other duties as assigned

Requirements:
  • BS or equivalent. Major in math, statistics or computer science preferred
  • At least 5 years relevant work experience or equivalent (biotech or pharmaceutical preferred) Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH and sound knowledge of SAS/STAT
  • Comprehension of CDISC requirements
  • Strong understanding of regulatory requirements
  • Practical experience with regulatory data summarization
  • Knowledge of clinical trial development process
  • Familiar with medical coding dictionaries (WHO, COSTART, MedDRA )
  • Ability to explain technical concepts clearly to non-technical colleagues
  • Excellent written, verbal and interpersonal communication skills
  • Strong organizational and analytical skills with ability to multi-task and prioritize work
  • Familiar with Oracle database applications (desired)

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