IQVIA
life sciences and healthcare industries
SeniorstatisticalProgrammer
“Senior statistical Programmer at IQVIA. Skills: SAS (Base and Macros), R, ADaM standards, SDTM. Creation of ADaM datasets based on current ADaM standards.. Creation of Tables, Listings and Figures following client specifications”
Industry & Context.
What They're Looking For.
Must Have
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., 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.
Nice to Have
Advanced degree (Master's, PhD or equivalent) preferred for Level 4., R, Python is a plus., 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.
What You'll Do.
Creation of ADaM datasets based on current ADaM standards.
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
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.
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.
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).
pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data.
documents and correctly manages the lineage between master standards and the many pre-configured standards.
How You'll Work.
Communication Scope
Demonstrated written and verbal communication.
Applying for this Senior statistical Programmer role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about IQVIA?
Real rants from real employees. Read before you apply.