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Title:Sr. Statistical Programmer
Salary:Open
Experience:2+
Location:NC - Durham

Description:

Statistical programming support for multiple Phase I studies.

Responsibilities:
  • Works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Identifies potential issues in statistical analysis plans and proposes solutions, assesses the quality of analysis data, performs cross-study analyses, uses internal macros or writes SAS® macros to automate statistical table, figure, and listing production;
  • Mentors junior programmers,
  • Assists in the preparation of submissions of electronic data (e.g., SAS® data sets) to regulatory agencies, and independently develops analysis file programs.
  • Works as a primary programmer for one or two Phase 1-3 studies and as a secondary programming contact for one Phase 1-3 study.
  • Contributes to strategic initiatives.

Requirements:
  • Typically requires a BS degree in Biostatistics/Computer Science or equivalent and minimum 4 years of relevant industry experience, or a MS degree in Biostatistics/Computer Science or equivalent and minimum 2 years of relevant industry experience in the statistical analysis of biomedical data using SAS® software.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Must be a fully qualified/emerging authority.
  • Thorough knowledge of clinical trial study design and electronic data submission requirements.
  • Must be able to work independently on multiple concurrent projects.
  • Must be capable of attending study team meetings as the primary statistical programming contact.
  • Ability to communicate with external vendors (e.g., Contract Research Organizations) regarding electronic submission issues.

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