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Statistical Programmer II

Statistical Programmer II

cGxPServePhiladelphia, PA, United States
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Job Description :

  • Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy.
  • The candidate programs SDTM / ADaM / TLFs for the studies, write datasets specification, QC datasets and tables. Identifying and communicating changes in project requirements that may affect key deliverables.

Responsibilities :

  • Involve in the programming activities on multiple projects / studies across various therapeutic areas, both internally and externally by CROs.
  • Create and review annotated CRF to SDTM datasets.
  • Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate,encourage and align people with the company's strategic objectives.
  • Function as a positive role model for setting high expectations for quality, creativity and project ownership.
  • Works collaboratively with Clinical Operation, Data Management,Global Drug Safety, Regulatory and Project Management management / staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Provide technical input into documents produced by other functions(e.g. biostatisticians, data managers, medical writers.
  • Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
  • Involved with the strategy for process improvement.
  • Identify new tools to increase efficiency and quality.

    • Requirements :

  • Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
  • Minimum of 4-7 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
  • Advanced SAS programming skills and experience in other statistical software,such as R and S-Plus
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
  • Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programing projects.
  • Excellent organizational skills and ability to prioritize tasks.
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    Statisticalprogrammerii • Philadelphia, PA, United States