Services Overview:
The services requested are for Statistical Programming for clinical trials Phase I – IV utilizing SAS (Base and Macros) and R.
Deliverables:
- Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Creation of ADaM datasets based on current ADaM standards.
- Creation of Tables, Listings and Figures following client specifications
- Creation of Subject Narratives following client templates to support Narrative development.
- Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
- QC of all programmed output
- Creation and/or maintenance of detailed specification documentation
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
- Includes support for standalone studies as well as integration of data across studies.
- Specific for CDSA – Analysis Standards focus area:
- The service holder is responsible to design, develop and maintain SAS code that is generic and that covers many trial types, can run on many study designs and meet study specific situations based on high reliable study metadata specifying the design and study specific situations.
- The service holder defines and maintains standard clinical data analysis metadata for use in clinical trials, including the traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).
- The service holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data. The service holder documents and correctly manages the lineage between master standards and the many pre-configured standards.
Education and Experience Requirements/Qualifications:
- Bachelor’s degree or higher and / or equivalent in computer science, mathematics, or other scientific field (or equivalent theoretical/technical depth). Advanced degree (Master's, PhD or equivalent) preferred for Level 4.
- Demonstrated written and verbal communication.
- Ability to work remotely.
- Knowledge of SAS is must and R, Python is a plus.
- Minimum 4+ years of experience
- High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data
- Working knowledge of clinical trial data (Study population, safety, efficacy, PK/PD) in the therapeutic are being serviced.
- Demonstrated understanding of current industry standards for submission of clinical trial data.
- Specific for CDSA – Analysis Standards focus area:
- Basic knowledge in industry standards, specifically Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and related Analysis Data Models (ADaM)
- Relevant operational experience in analysis standards (ADaM metadata and SAS Code) is preferred.
- Experience with Therapeutic Area User Guides (TAUG) is a plus.
R Skills:
- Possesses foundational R programming capabilities that enable working with data and performing simple analyses.
- Demonstrates understanding of R syntax and basic data structures, can import and export datasets, and create basic data visualizations.
- These skills support straightforward data manipulation and exploratory analysis tasks.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
