Clinical SAS Programmer
Company: Katalyst HealthCares & Life Sciences
Posted on: March 19, 2023
- Providing statistical programming and validation support for
clinical study reports, overseeing programming activities by
external vendors (e.g., CROs) when necessary and coordinating
programming activities among the study programmers to achieve
timely progress in the following areas: SDTM datasets, ADaM
datasets, statistical tables, figures, listings, and other internal
and external requests (e.g., publications).
- ccessing and converting data to SAS from Database management
system and PC file formats (e.g., MS Excel, text files).
- Working with external vendors in order to develop or monitor
the content and structure of SAS data sets.
- Working closely with clinicians, statistician, and publication
managers to generate and QC outputs for publications; review
publication (abstract/manuscripts) to ensure accuracy, quality, and
soundness of statistical methodologies; coordinate internal
resource utilization for publication and generate activities
metrics for management review.
- Providing input to the Database and CRF Development, creating
edit check programs and providing feedback to the Data
- Providing input in developing statistical analysis plans,
specifications of analysis datasets, validation plans, and other
- Maintaining standards for programming activities.
- Working independently to accomplish tasks and goals defined by
- Bringing in new ideas to improve the programming process.
- Minimum 10+ years' experience in SAS programming for phase
- clinical trials in a pharmaceutical/CRO environment. FDA
submission experience preferred.
- Some project experience in a pharmaceutical/CRO
- environment or demonstrated leadership in a clinical
- Skills and aptitude required:
- Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS
- Experience in CDISC data standards, e.g., SDTM and ADaM
- Proven experience with Unix and Windows operating systems.
- Understanding of the software development life cycle.
- Understanding of FDA guidelines.
Keywords: Katalyst HealthCares & Life Sciences, Boston , Clinical SAS Programmer, IT / Software / Systems , Boston, Massachusetts
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