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Programmer - United States  

Iterum Herapeutics (company)

Posted on : 20 October 2017

Project Description

The Programmer supports the Biostatistics team by carrying out and overseeing programming activities of statistical programmers and external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.

Primary Responsibilities:

The main responsibilities of this role may include, but are not limited to::

  • Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
  • Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
  • Managing and developing team, maintaining standards for programming activities, and guiding/coaching Statistical programmers.
  • Working independently to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process. * Responsibilities weighting may change significantly based on the incumbent and their assigned areas of responsibility.

Training and Education:

  • Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline.
  • Master’s Degree in statistics or related discipline prefered.

Prior Experience:

  • Minimum 5 years of experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
  • Seven years programming experience and FDA submission experience.
  • Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment.