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Title:Senior Clinical SAS Programmer Analyst I
Salary:Open
Experience:4+
Location:MD - Gaithersburg

Description:
Interacts directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as a member of the clinical programming team.

Responsibilities:
  • Provides critical clinical programming support to projects; failure can cause significant delays for organization.
  • Keeps the Project Lead Programmer apprised of status, accomplishments and issues.
  • Works under general direction of the Project Lead Programmer and / or Manager - seeks feedback when needed.
  • Leads the development and documentation of mapping specifications for creating analysis datasets.
  • Implements standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan for inclusion in the clinical study report. Responds to ad-hoc requests.

Requirements:
  • Conducts programming validation when needed.
  • Applies advanced SAS skills to develop robust, flexible standard macro programs.
  • Ensures the compliance of standards in the programming assignments.
  • Reviews and provides feedback on case report form designs, CRF annotations, DB structures, edit checks, SAPs and SPPs.
  • Able to create adequate solutions for complex requests.
  • Plays a major role programming on one or more protocols.
  • A minimum of 4 years of clinical trial programming experience using SAS within the pharmaceutical, biotechnology, and/or contract research organization industries.
  • Advanced SAS programming skills with proficiency in SAS/BASE and its macro facility, SAS/STAT and SAS/GRAPH.
  • Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes.
  • General knowledge of medical terminology and clinical trials methodology.
  • Excellent verbal, written and interpersonal communication skills.
  • Excellent collaborative skills and the ability to manage complexity and change in a dynamic environment
  • Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree preferred.

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