SAS Programming

Please contact us if you would like to inquire further about our statistical programming services.

Contact Us
NJS Associates has more than a decade’s worth of submission experience. We have developed individual study reports and Integrated Summaries (ISS & ISE), for both NDA and BLA submissions. Our expert programmers are very knowledgeable about FDA Electronic Submission Guidelines and CDISC specifications.

CDISC data standards, industry data standards, and FDA compliance are always at the heart of every statistical programming task that we undertake. You can always rely on our team of highly skilled programmers, comprehensive project management check lists, and strict validation processes to deliver high-quality statistical programs and output.

We offer a range of ‘flexible’ contractual engagement models ranging from project outsourcing, functional insourcing (FSP), and contract staffing.

SAS Programming

  • aCRF Implementation
  • Patient Profile
  • Study TLF production
  • CDISC (SDTM and ADaM, Define[dot]xml, Define[dot]pdf, SDRG, ADRG) Dataset production
  • Legacy Data Conversion to CDISC standards
  • Clinical Study Reports ISS/ISE
  • eSubmission

Expert SAS Programming Support

  • Derived Efficacy Endpoints for Oncology Trials (Time-To-Event, PRO, Response)
  • Development of Customized application macros
  • Data Quality Check in RECIST, iRECIST, Response under Cheson, PCWG etc.
  • Data Visualization
  • Interactive Data Review
  • Ad hoc Analysis

Other Services

Biostatistics

Strategic Planning for Clinical Development, Endpoint selection, Study design, Submission strategy, SBA Review, FDA communication.

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FSP

We offer a range of ‘flexible’ contractual engagement models ranging from project outsourcing and  functional insourcing (FSP).

Learn more