Industry: Pharmaceuticals & Biotech•
5 - 7 years
Posted 62 days ago
Summary of Duties:
Perform advanced bioinformatics programming activities for the statistical and computational consideration of research projects including some or all of the following: creation and maintenance of programs used for data entry, data management, data validation, statistical report generation, and program validation. Prepare and analyze clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes. Consult with researchers and multi-disciplinary project teams to analyze problems and recommend technology-based solutions and computational strategies. Develop the customized codes to utilize existing PPD standard tools and applications to provide the outputs for clinical bioinformatics or technical use. Create novel computational approaches, or dynamic programming as required by project plans. Assist Data Management and Biostatistics by recommending efficient optimal systems and processes to improve operations and process efficiencies. Act in programming lead role on complex studies, representing the Biostatistics department within the company or client. Confer with departments, such as Data Management, Clinical Team Management, Project Management, Commercial Finance, or Biostatistics, to coordinate project development and improvement. Provide input to the bid-ding process. Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generate and store summary data from a variety of sources, and generate reports or combine multiple databases. Independently create, execute, maintain, and validate programs that generate listings, tables, and figures using SAS. Serve as a project lead and oversee the work of other programmers on the team. Assume leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team. Supervise, train, and mentor other programmers. Participate in developing SOPs and working practice documents. Duties may be performed remotely.
Master’s degree in a scientific, technical, or quantitative field and three (3) years’ experience in the offered role or as a Statistical Programmer/Analyst or related. Employer will also accept a Bachelor’s degree in a scientific, technical, or quantitative field and five (5) years’ experience in the offered role or as a Statistical Programmer/Analyst or related. Experience must include three (3) years with: SAS programming; Data set structures and working with complex data systems; Windows office applications; SAS Macro; Clinical research and trials; and Quality control support. Must also include one (1) year experience with: Project management; and FDA, CDISC, ADaM, and SDTM standards.