Statistical Programmer

CGxPServe

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profile Job Location:

Irvine - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Responsibilities:
  • This person will be responsible for development and generation of analysis datasets tables listings and graphs from assigned clinical sources using SAS and/or R; leading development and maintenance of associated operating procedures; and participating in external industry forums (e.g. CDISC SDTM and relevant User Groups).
  • This individual performs with minimal guidance on moderately difficult deliverables.
  • Utilize programming standards to develop efficient and accurate programs using SAS and/or R.
  • Support creating and/or maintaining Programming Infrastructure in SAS and/or R.
  • Support in developing and maintaining R scripts for data analysis statistical modelling and visualization is a plus.
  • Keeping up to date with the latest R packages techniques and best practices is desirable.
  • Work with Data Management leadership to provide input on reporting processes and standards.
  • Support programming deliverables for clinical trials and support for any custom Data Management reports.
  • Participate in the development and maintenance of global harmonized processes and procedures for programming.
  • Provide quality programming deliverables.
  • Facilitate the delivery of standard metric reports.
  • Ability to design implement and maintain moderately complex programming deliverables across a wide variety of clinical platforms and thereputic areas.
  • Conduct independent QC programming and peer review of code and deliverables.
  • Demonstrated ability work in teams to deliver critical milestones.
  • Connect Participate in strategic partnerships with Clinical and Biostatistics functions at the Enterprise level to ensure MD programming practices meet the needs of the organization.
  • Shape Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine SDTM standards.
  • Lead Present opportunities in programming practices that increase quality of deliverables.
  • Deliver ensure high quality programming deliverables for clinical programs are delivered on time and in compliance to regulations and SOPs seamlessly across all Franchises.
Requirements:
  • A bachelors degree in Statistics Computer Science or related discipline (required).
  • Minimum 4 years of system support in clinical research within Medical Device or Pharmaceuticals.
  • Proficiency in Base SAS SAS/STAT and SAS Macro language.
  • Strong debugging problem-solving and documentation skills.
  • Excellent verbal and written communication skills.
  • Support the maintenance of established SAS platform.
  • Support the maintenance of a global SAS macro library.
  • Work with Clinical Data Science (CDS) partners and leadership in Clinical Operations and Franchise to set implement plans for timely delivery of reports metrics and study deliverables.
Responsibilities: This person will be responsible for development and generation of analysis datasets tables listings and graphs from assigned clinical sources using SAS and/or R; leading development and maintenance of associated operating procedures; and participating in external industry forums (...
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