Our Services
Statistical SAS programming expertise for clinical trials
Statistical SAS Programming
Programming of datasets, tables, listing and figures to support different projects using SAS.
Usage of SAS statistical procedures to support the statistical analysis of the project. Survival analysis, mixed models, parametric and non- parametric tests are just a few of the statistical methods for which we have experience.
Macro creation using SAS.
Expertise, including adherence to GCP/GPP/GxP and any industry or client standards.
Validation and creation of associated documentation for the tasks we perform.
Statistical Programming Project Management/Leadership
Act as Lead Programmer for one or multiple projects with input for the entire duration of a project.
Plan the study deliverables in collaboration with other functions and lead/manage a team of programmers to meet the project plans and timelines.
Author or review study documents from a statistical programming point of view.
CDISC Expertise
CDISC standards expertise including writing specifications and programming of SDTM and ADaM datasets.
Expertise on complex efficacy ADaM datasets including but not limited to oncology specific datasets for incorporation of RECIST v1.1 endpoints and time to event analysis.
Creating define.xml and writing of SDRG and ADRG.
Clinical Trials and Real World Evidence Data Usage Expertise
Experience with clinical trails of all phases as well as real world data of multiple indications including oncology, cardio-vascular, respiratory, nephrology, dermatology, neurology.
RECIST v 1.1. implementation expertise on oncology studies.
Review of study documentation including but not limited to Clinical Study Protocols, CRFs, Statistical Analysis Plans, TLF shells, Data Management related documents and third party data specifications.
Standard creation support for third party data collection.
Other
Collaboration with other functions (Statisticians, Data Management, Clinical Team, Project Physicians etc.) for the creation of different tools using SAS and programming support for regulatory submissions.
Adaptability to work in multi-cultural environments and with teams located in different time-zones.