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Title:Lead Statistical Programmer
Salary:Open
Experience:3-5
Location:NJ - Montville

Description:
Works independently and assumes responsibility for the development and use of standard programs and statistical project data structures for all studies within the project.

 

Responsibilities:
  • Act as Lead Project Statistical Programmer
  • Ensures timely creation of submission data/analysis documentation package according to regulatory guidelines.
  • Responsible for statistical programming activities at a study level and participate in project level programming.
  • Contribute to the creation, quality, implementation, and timeliness of the Statistical Programming and Submission Support deliverables.
  • Provide programming support, including documentation and validation, for producing analysis data sets, submission ready datasets, pooled data sets, integrated databases, listings, summaries, figures, and tables for Phase I-IV clinical studies, integrated safety analyses, integrated efficacy analyses, health authority and publication requests .
  • Oversee the completion of programming for all tables, listings, and graphs .
  • Attend and contribute to Study Team meetings, discussions, and activities covering aspects of all Statistical Programming and Submission Support .
  • Participate as a team member in IND/NDA activities, as needed for assigned projects .
  • Ensure timely completion of programming for all tables, listings, and graphs .
  • Ensure SAS validation procedures are followed .
  • Contribute to and review documents for assigned studies e.g., protocol, CRFs, Statistical Analysis Plans, Project / Integrated Analysis plans for Phase I-IV clinical studies .
  • Establish, maintain, and perform quality control, and produce documentation of study clinical data bases from hand-over from Data Management up to hand-over to regulatory function, in accordance with study evaluation and clinical summary requirements .
  • Transform of acquisition data delivered by Data Management to analysis data sets for statistical evaluation .
  • Coordinate the exchange of data, analysis data, analysis programs and statistical deliverables with external units, receiving and transmitting data and incorporating them in the directory structure .
  • Program the transformation of analysis data sets to submission data format for health authorities, provide respective documentation .
  • Provide accurate and timely creation of submission data sets, submission program code and corresponding documentation to support electronic submissions to regulatory authorities for marketing approval .
  • Participate in global teams to implement system / data format changes effected by the changing regulatory requirements
  • Assist in the design, specification, development, evaluation, testing, and selection of systems and software for use in the statistics function .
  • Ensure that adequate user documentation exists for internally programmed tools

Requirements:
  • BS/MS in Statistics, Mathematics, Computer Science or equivalent (of theoretical/technical depth)
  • 3-5 years of pharmaceutical experience in clinical programming and submission preparation
  • 3-5 years statistical programming SAS in Pharma or Biotech
  • Thorough understanding of good programming practices and methodology
  • Good understanding of health authority regulations and guidelines regarding programming and computer system validation
  • Experience working in international environments and good intercultural communication skills
  • Strong written and oral communication skills
  • Ability to work within a team environment

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