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Thứ Hai, 30 tháng 3, 2015

Clinical Programmer - Advanced Clinical - Watchung, NJ

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OVERVIEW


  • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.

  • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.

  • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.

  • Ensure consistency and adherence to standards within their therapeutic area.

  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.

  • Serve as the lead programmer in support of NDAs, sNDAs.

  • Oversee the services provided by CROs.

  • Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.

  • Provide training on departmental SOPs/WPs and standard programs.

  • Contribute to the creation of naming conventions and standards for the programming environment.

  • Participate in industry wide technical discussions.




Skills/Knowledge Required:


  • Bachelors degree in life science, statistics, mathematics, computer science, or related field is required; Masters degree is preferred.

  • 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelors degree; or 8 plus years experience with a MS/MA degree.

  • Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs.

  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.

  • Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).

  • Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.

  • Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.

  • In-depth understanding of regulatory, industry, and technology standards and requirements.

  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.

  • Demonstrated ability to work in a team environment with clinical team members.

  • Excellent planning and project management skills.

  • Good interpersonal, communication, writing and organizational skills.

  • Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC. ]]




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