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Job Location drjobs

others - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

Responsibilities:
  • Efficient programming techniques.
  • Creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
  • Contribution to and review of statistical analysis plans and analysis datasets specifications.
  • Prepare the electronic submission of clinical trial data to regulatory authorities.
  • Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
  • Provide effective solutions for complex statistical programming tasks.
  • Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
  • Create and manage the project and study electronic subdirectories ensuring consistency in structure.
  • Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
  • Participate in the development of new processes or revision of existing processes.
  • Keep current with new statistical programming techniques and technological advancements.
  • As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex statistical programming techniques.

Requirement:
  • Bachelor's Degree in Statistics/Biostatistics, Computer Science, or Mathematics.
  • 5+ years of experience as a statistical programmer in the pharmaceutical industry
  • Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
  • Technically strong with regard to statistical programming processes and activities.
  • Highly proficient in SAS .
  • Experience as a lead statistical programmer on several concurrent projects.
  • Understanding of CDISC STDM/ADaM guidelines.
  • Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Employment Type

Full Time

Company Industry

About Company

100 employees
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