Senior Statistical Programmer

IQVIA

. The services requested are for Statistical Programming for clinical trials Phase I – IV utilizing SAS (Base and Macros) and R.

Posted 5/12/2026full-timeRemote • 🇹🇼 TaiwanSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformPython

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

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.
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.
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.
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.

Benefits

Comp & perks

Ability to work remotely.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SASSAS MacrosRPythonADaMSDTMclinical trial data analysisdata visualizationdata lifecycle managementspecification documentation

Soft Skills

written communicationverbal communication

Certifications

Bachelor's degreeMaster's degreePhD