Katalyst Healthcares & Life Sciences
Senior Statistical Programmer
Katalyst Healthcares & Life Sciences, Basking Ridge, New Jersey, us, 07920
Responsibilities:
Perform data manipulation, analysis and reporting of primarily clinical trial data
Program and generate tables, listings, and graphs (TLGs)
Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
Participate in study team meetings and address issues that may affect statistical programming.
Validate and document SAS programs and output.
Create SDTM and ADaM Datasets and related documentation.
Fulfill ad-hoc programming requests.
Other duties as needed.
Requirements:
15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies.
Strong submissions experience (BLA, NDA/sNDA and EMA) and end to end programming experience.
Knowledge and experience working with CDISC Standards (MUST have expertise in both SDTM/ADaM, developing specifications for both).
Demonstrated ability performing all levels of programming activities for a clinical project.
Experience working in the Cardiovascular or Neuromuscular areas is a plus.
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Perform data manipulation, analysis and reporting of primarily clinical trial data
Program and generate tables, listings, and graphs (TLGs)
Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
Participate in study team meetings and address issues that may affect statistical programming.
Validate and document SAS programs and output.
Create SDTM and ADaM Datasets and related documentation.
Fulfill ad-hoc programming requests.
Other duties as needed.
Requirements:
15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies.
Strong submissions experience (BLA, NDA/sNDA and EMA) and end to end programming experience.
Knowledge and experience working with CDISC Standards (MUST have expertise in both SDTM/ADaM, developing specifications for both).
Demonstrated ability performing all levels of programming activities for a clinical project.
Experience working in the Cardiovascular or Neuromuscular areas is a plus.
#J-18808-Ljbffr