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Sr. Statistical Programmer
Ref No.: 18-33978
Location: Pleasanton, California
Position Type:Contract
Start Date / End Date: 05/28/2018 to 11/28/2018
Job Summary:
Sr. Statistical Programmer will be responsible for supporting statistical programming activities for registrational and non-registrational studies. Participates as part of a study team and contributes towards developing, validating, and documenting programs written using SAS software to meet the study needs. In this role, programmer will be accountable for the implementation and delivery of complete and accurate data and reports to support regulatory submissions. Organizes and facilitates programming tasks to ensure timely study deliverables.  Depending on the complexity, may have primary ownership of one or more studies.
 
Essential Functions
  • Functions as the primary point of contact for programming related tasks for assigned study.
  • Under minimum guidance, develops and modifies SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency.
  • Develops all extraction programs to create raw datasets related to the study.
  • Develops source and analysis datasets from raw data to support the analysis of clinical trials data.
  • Responsible for creating data specifications to generate source and analysis datasets as per the study requirements.
  • Creates tables, figures, and listings to support clinical study reports and electronic submissions.
  • Develops, validates and maintains global tools such as SAS macros that increase the efficiency of the programming.
  • Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests.
  • Validates, documents and archives single-use programs as per department SOPs under proper guidance.
  • Leads data discrepancy process within a study.
  • Experience in creating submission documents necessary to support submissions to regulatory agencies in electronic format.
  • Reviews outputs to ensure consistency across programs within study.
  • Reviews and provides input for CRFs, edit check specifications, SAP and table mock-ups.
  • Review, maintain, and approve study documents per standard procedures.
  • Uses discretion and independent judgment to consider and determine appropriate solutions/actions to a range of problems.
  • Participate in the development and/or maintenance of departmental procedures and standards.
 
Qualifications
Education:    
Minimum:        Bachelors degree in scientific discipline.
Preferred:        Masters degree in scientific discipline.
Experience:  
Minimum:        5 years experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment.
Preferred:        7 or more years experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment.
Knowledge, Skills and Abilities:
  • Must have knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH.
  • Familiarity with statistical software, statistical analyses and databases.
  • Strong verbal and written communication skills.