Clinical SAS Programmer
Company: Katalyst Healthcares & Life Sciences
Location: South Plainfield
Posted on: March 20, 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: analysis datasets,
statistical tables, figures, listings, Integrated Summaries of
Safety (ISS), Integrated Summaries of Efficacy (Client), DSUR,
PSUR, IB, progress reports, electronic submissions and other
internal and external requests (e.g., publications).
- Accessing 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.
- SDTM and ADaM technical knowledge required. In addition,
knowledge of agency requirements including ICH, FDA, and other
guidance is strongly recommended.
- Knowledge of current FDA submission process (Define.xml, etc.)
is strongly recommended.
- Developing and maintaining SOPs, SWPs and other related
technical documents, providing input to the Database and CRF
- Providing input in developing statistical analysis plans,
producing specifications of analysis datasets, validation plans,
and other related documents. Good understanding with different
phases of clinical trials, protocols, and CRF designs.
- Maintaining standards for programming activities (SDTM, ADaM,
directory structure, etc.), and guiding/coaching Statistical
- Working independently as well as in teams to accomplish tasks
and goals defined by supervisor. Attending required training and
meetings and bringing in new ideas to improve the programming
- Minimum of bachelor's degree in Statistics, Computer Science,
Mathematics, or a related science discipline. Masters strongly
preferred. Strong educational background is expected.
- 5-7 years of experience in SAS programming in biostatistics
department environment for phase I-IV clinical trials in a
pharmaceutical/CRO environment. Lead Programmer experience is
- Strong managerial / technical understanding of programming and
clinical related issues along with an ability to demonstrate
significant leadership of SAS programming technical activities in a
clinical pharmaceutical/CRO environment.
- Understanding of submission-related activities and experience
with agency-related requirements expected.
- XML knowledge and familiarity with a submission process is
- Oncology and in-depth ADaM programming required.
- Submission support with compliance is expected. (This text is
what was sent to you earlier and should be ok.)
- Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS
Office. Knowledge of SDTM and ADaM standards.
- Proven experience with UNIX and Windows operating
- Understanding of the software development life cycle and FDA
Keywords: Katalyst Healthcares & Life Sciences, New York , Clinical SAS Programmer, IT / Software / Systems , South Plainfield, New York
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