Clinical SAS Programmer II
Company: Katalyst HealthCares & Life Sciences
Location: South Plainfield
Posted on: March 20, 2023
- Develop statistical programming for the production or
validation of analysis datasets, tabulations, graphics, and
listings from clinical databases and other clinical data sources
based on programming specifications and statistical analysis plans
- Develop specifications to define program requirements used to
generate analysis datasets, tables, listings and figures. Provide
support for the development of specifications and programming for
operations activities such as data transfers, edit checks and
trending reporting based on specifications.
- Provide technical support and propose innovative technologies
for automation of operations activities.
- Write SAS programs to generate derived analysis datasets,
perform analysis, validation and reporting of clinical data.
- Perform ad hoc flexible and rapid programming arising from
questions generated from planned analyses and results.
- Review and assist with maintaining existing SAS programs as
- Contribute to the preparation and review of statistical
analysis plans including mock table, figure and listing shells to
ensure they are aligned with the CRF and study goals. Provide
programming review of CRF to ensure adherence to regulatory and
CDISC standards and ensure alignment with study goals.
- Establish and maintain positive relationship with the study
team that fosters confidence, facilitate problem resolution, and
enhance the integrity of data and deliverables.
- Prepare, document and test required programs and procedure data
displays in an efficient manner for inclusion in integrated
clinical, statistical reports and other similar reports.
- Work efficiently to provide high quality programming solutions
that meet or exceed industry standards and regulatory requirements.
Ensure that study databases and statistical programs used within
the CPC comply with GCP, FDA and ICH guidelines and CPC
- Effectively document and communicate requirements, timelines
and progress of deliverables/projects.
- Work collaboratively with other departments at CPC to optimize
cross department functionality.
- Provide weekly feedback to the supervising programmer or
biostatistician on the progress of deliverables/projects.
Contribute to the development and maintenance of standardized
programming methods including departmental standards, global use
macros and program libraries. Follow and contribute to new
department and company standards in programs, datasets and
- Assist in the development and maintenance of programming
procedures and related training activities.
- Stay current on new SAS developments by regularly attending
user group meetings, reading SAS related publications, taking SAS
courses and/or interfacing with SAS institution personnel.
- A degree in a related field or SAS certificate preferred.
- A minimum of 4 years of experience programming in SAS (v9.2+),
preferably in a Windows environment.
- A minimum of 2 years of experience working in the
pharmaceutical or biotechnology industry or other regulated
- Proficiency in all basic SAS computing functionality and common
data summarization and analysis strategies and procedures.
- Demonstrable programming experience with SAS macros, ODS,
Reporting, Graphics, proc SQL, and Excel.
- Significant experience with developing and conversion of
datasets to meet CDISC standards including SDTM and ADaM
- Expertise in areas such as complex macro programming, enhanced
graphics display, other programming languages e.g. R, Python is a
- Knowledge and experience with utilization of SDTM and ADaM
standards, tables, listings and graphs in support of pharmaceutical
- Attention to detail, excellent organizational and team
- Demonstrated ability to work in a team environment with
clinical team members.
- Knowledge of statistical terminology, clinical tests, medical
terminology and protocol designs.
Keywords: Katalyst HealthCares & Life Sciences, New York , Clinical SAS Programmer II, Healthcare , South Plainfield, New York
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