Statistical Programming

Expertise in SAS-based Statistical Programming

NDS Statistical Programming teams include Project Managers, Senior Programmers, and/or Lead Programmers. The Project Manager manages the day-to-day workload of the team. Technical or programming issues are reviewed at the weekly team meeting. If an issue has not been resolved, then a Principal Consultant (who are the most senior technical employees of NDS) is asked to step in and help resolve the issue. The Project Manager and Lead Programmers function as Statistical Programmers.

The value these separate Manager and Lead functions bring to the client is manifold. A Project Manager will manage all aspects of a project, from resource allocation, to timelines, budgets, and quality. However, hour-by-hour leadership on a smaller scale is effectively provided by our Lead Programmers, whose key contributions include managing specific tasks on a subset of the project.

NDS can provide US Based Statistical Programmers along with Global Statistical Programmers. All have been trained in CDISC. Our Leads and Project Managers function as part of the Statistical Programming team, performing all the same tasks as any programmer – generating datasets, up to and including SDTM and ADaM specifications, and conversation of data to CDISC Standards and generating output (TLFs).

Your reliable data scientists to gain insights to enable better decisions

  • analytics

    Anticipate the progress of the trial

  • decision

    Intelligent decisions to drive better decisions

  • data_nds

    Transform data from clinical trials to understandable information

  • settings_nds

    Match changing clinical trial needs

Gain the Navitas Data Sciences Edge

Utilize our Statistical Programming expertise under a Functional Service Provider model to enhance your clinical trials. We are adept at analyzing clinical trial data to deliver concise and compliant outputs.

Our SAS Programming Teams Deliver

  • Tables, Listing, and Figures (TLFs)
  • CDISC Global Standards - CDASH, SDTM, ADaM, eCTD, and Creation of Define.xml
  • Analysis Datasets
  • Ad Hoc SAS Programming
  • Statistical Analysis Programming
  • SAS Macro Development
  • QC and Verification Programming
  • PK/PD Programming
  • Clinical Study Report, ISS/ISE, and Annual Report Support
  • Registry, Post Marketing Data Analysis, and Manuscript Support
  • R Programming
  • Data Migration and User Acceptance Testing
  • Legacy Data Transformation and Visualization
  • Navitas Data Sciences' CR Toolkit™ Software

Trust our Stellar Expertise in SAS programming

You will be working with highly skilled and experienced people as project managers, leads and senior programmers. You can rely on our vast experience to guide you successfully through the most complex of clinical trials.

The need for highly skilled and talented SAS programmers is rapidly rising due to the need for such expertise and the dearth of availability. Our SAS programmers are always in demand as we ensure quality delivery, on time. QC Verification/Validation, SAS programming, Standard Operating Procedures (SOPs), and IT Projects are examples of the work typically performed by our experts.

Our Global Presence

Navitas Data Sciences has a global presence, with offices spread out in the U.S and in India. Our parent organization, Navitas Life Sciences has 60 offices spread across 12 countries.

Support for CDISC - SDTM AND ADAM

We perform SDTM and ADaM dataset development and QC verification/validation. We will work with you closely to understand your needs and use this information to ensure a successful CDISC compliant conversion. In fact, we have a specially developed checklist with 10 components that we use at the start, as a structured means of understanding your requirements.

CDISC Conformance and Review Process

The Pinnacle 21 is used for validation, and the conformance and review process include validation and conformance to:

  • CDISC SDTM
  • Implementation Guides
  • Review of data, datasets, and CRFs to CDISC Metadata Submission Guidelines and the PHUSE Study Data Review Guide (SDRG)
  • Define.xml standards for specified version

Report of SDTM/ADaM Findings and Possible Remediation

We work with you to remediate any findings identified during the SDTM, ADaM, Reviewers Guide and define.xml review process that need corrective action or discussion.

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