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SAS Programmer

SAS Programmer

cGxPServeAtlanta, Georgia, USA
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Responsibilities :

  • The statistical programming contractor independently manages completed projects that involve global tasks or cross functional teams.
  • The role may require providing inputs to design and analysis and reporting the results of clinical trials including programming rules and mocked T / L / G In addition providing programming support for publication for our marketed drugs Primarily works at the study product / program level.
  • Provides comprehensive programming support including development of programs ADaM specifications analysis (datasets TLGs) complying with regulatory requirements departmental SOPs and work practices.
  • Manages and Delivers assignments with good quality and within timelines.
  • Provides programming support to CDISC based e-submission.
  • Develop debug and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs.
  • Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps
  • Responsible for the standardization of GSD deliverables (datasets and associated TLGs) across study projects within an indication / therapeutic area.
  • Provides input on opportunities for process improvement Proactively communicates issues impacting programming deliverables with Stat or DM team members.
  • Influences communication toward common understanding and actionable results.
  • Tackles difficult problems; Identifies solutions and help leading decisions to resolve.
  • Manage and deliver assignments with quality and within timelines by being independent and proactive.

Requirements :

  • Bachelors Degree / masters degree in science Statistics Information Technology or equivalent combination of education and related work experience.
  • Bachelors 7 year Masters 6 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
  • Proficient knowledge of clinical trials and drug development process industry standards statistical concepts used in analysis and submissions of clinical trial data.
  • Strong understanding of SDTM ADaM standards and Implementation guides.
  • Demonstrated proficiency in using SAS to produce analysis datasets TLGs eSUB components and using other software applications.
  • Pinnacle 21 XML and MS Office) Demonstrated ability to work independently and in a team environment.
  • Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study / project.
  • ISS / Client) creation of Bioresearch Monitoring (BIMO) Inspection deliverables).
  • Have solid knowledge of statistical models used for efficacy data analysis. Company / Industry Related Knowledge : Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
  • Core essential skill sets candidates must have to be considered for the role : Expert level of programming skills and problem resolution in SAS
  • Advanced knowledge of government regulations (such as CDISC and ICH guidelines) pertaining to drug development in multiple therapeutic areas.
  • Solid Statistical Knowledge.
  • Good oral and written communication skills.
  • Key Skills

    Databases,SQL,FDA Regulations,R,Relational Databases,Data Management,Data Structures,Clinical Trials,Statistical Software,CDISC Standards,SAS,Oracle

    Employment Type : Full-time

    Experience : years

    Vacancy : 1

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