Senior Clinical Programmer

Statistics and Data Corporation

Waltham - Telecommute

Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, and data quality edit checks to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of systems. Communicates with the end-users. Mentors/trains junior level clinical programmers.

Primary Responsibilities:

  • Assist in developing, validating, and maintaining clinical databases for clinical trials using a variety of validated software applications including Medidata RAVE, RAVEX, and Custom Functions
  • Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans
  • Build and validate data entry screens (paper and/or electronic data capture (EDC))
  • Implement and test data quality checks in accordance with the study data validation manual
  • Assist in developing and maintaining global library of clinical database forms, edit checks, and other regularly used programs and routines
  • Utilize copies of like database elements from library structures or other similar studies during builds
  • Batch load external data from vendors (e.g., central lab data)
  • Participate in internal and external team meetings, as necessary
  • Assist in management of user access to clinical databases
  • Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug
  • Participate in writing departmental documentation (e.g., training documents, process guidances)
  • Participate in other clinical programming and data management activities, as required
  • Mentor junior level clinical programmers
  • Adhere to all aspects of the Statistics & Data Corporation’s quality system
  • Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
  • Perform other related duties incidental to the work described herein

Requirements

Required Skills:

  • At least six years’ experience assuming lead database programming responsibilities on projects, with a minimum of 3 years in a clinical environment

  • Excellent understanding of relational database structures

  • Fast, accurate programming skills using assorted application software

  • PL/SQL, SQL, and XML programming skills

  • Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships

  • Demonstrated ability to provide both “user-friendly” and technical documentation

  • Ability to provide expertise to guide department in continued efficiency and growth

  • Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP)

  • Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment

  • C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable

  • Medidata Rave knowledge required including certifications and CF programming

  • Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge / experience not required, but desirable

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Education or Equivalent Experience:

  • Bachelor’s degree in computer science or other quantitative or scientific discipline with 6+ years’ experience in database programming and demonstrated working knowledge of scientific principles.
  • Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree
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