Katalyst Healthcares & Life Sciences
Senior Statistical Programmer
Katalyst Healthcares & Life Sciences, Princeton, New Jersey, us, 08543
Responsibilities:
Develop or review and QC CDISC-compliant datasets (SDTM & ADaM) and corresponding documentation for electronic submission.
Develop SAS programs to generate or QC displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies, internal deliverables, and publications.
Ability to write new SAS macros or incorporate existing SAS macros into individual programs.
Review and provide input on key study-related documents (e.g., CRFs, SAPs, etc.).
Review and remain compliant with SOPs and Technical Guide documents related to Statistical Programming.
Review and update documentation for tracking programming assignments and progress.
Other tasks related to statistical programming efforts as required.
Requirements:
7+ years of statistical programming experience in life sciences.
Recently experience working in a small team/small company environment (Sponsor).
Skilled SAS programming expertise and the ability to program CDISC datasets from scratch (SDTM & ADaM).
Ability to jump into a complex study and get up to speed quickly with little to no training time.
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Develop or review and QC CDISC-compliant datasets (SDTM & ADaM) and corresponding documentation for electronic submission.
Develop SAS programs to generate or QC displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies, internal deliverables, and publications.
Ability to write new SAS macros or incorporate existing SAS macros into individual programs.
Review and provide input on key study-related documents (e.g., CRFs, SAPs, etc.).
Review and remain compliant with SOPs and Technical Guide documents related to Statistical Programming.
Review and update documentation for tracking programming assignments and progress.
Other tasks related to statistical programming efforts as required.
Requirements:
7+ years of statistical programming experience in life sciences.
Recently experience working in a small team/small company environment (Sponsor).
Skilled SAS programming expertise and the ability to program CDISC datasets from scratch (SDTM & ADaM).
Ability to jump into a complex study and get up to speed quickly with little to no training time.
#J-18808-Ljbffr