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# Principal Statistical Programmer

- **Company:** Clinvia LLC
- **Location:** United States
- **Experience:** Expert
- **Salary:** $138,965.0
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Clinical Data Repository, Computer Programming, Data Validation, SAP (Applications), SAS (Software), SAS/Base, SAS/STAT, SQL Databases, Macros, Data Management
- **Published:** June 3, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=bec96de6aa37204b

## About the Role

Do you have experience in Regulatory submissions?, Do you have a Bachelor's degree?, * Minimum 8 years Pharmaceutical/Biotech programming experience.

 * NDA submission experience and knowledge required.
 * Strong SAS programming and Statistical background along with experience with SAS Base,

SAS/Macros, SAS/Graph and SAS/Stat.

 * Education Requirements (degree, certifications, etc.): Include must have and preferred

BS/MS in Statistics, Math or Scientific Discipline.

## Description

* Project lead level activities.
 * Performs data analysis using primarily the SAS programming language for the summary

and interpretation of clinical trial data.

 * Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic

Submission from the data received in non-standard form from various sources.

 * Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and

graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

 * Review Data Management Plan, Data validation plan and edit check specifications
 * Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate

outputs according to the requirements.

 * Implements and contributes to statistical analysis plans; provides additional expertise in

the analysis of clinical trial as it relates to protocol development, case report form design

and data collection.

 * Recognizes inconsistencies and initiates resolution of data problems.
 * Exercises independent judgment in developing methods, techniques and evaluation

criteria for obtaining results.

 * Works on significant and unique issues where analysis of situations or data requires

evaluation of intangibles.

 * Acts independently to determine methods and procedures on new assignments.
 * May provide guidance to other lower level personnel.
 * Works closely with Biostatistics to create analysis files specifications following the

instructions provided in Statistical Analysis Plan (SAP)

 * Develop SAS coding and table templates for preparing, processing and analyzing clinical

data.

 * Create/acquire tools to improve programming efficiency or quality.
 * Establish monitoring of data transfers for ongoing trials to identify study conduct or data

quality issues.

 * Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.


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