Katalyst Healthcares and Life SciencesIrvine, CA, United States
1 day ago
Job type
Full-time
Job description
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 bachelor's 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.
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