Clinical Programming

West Chester, PA, US • Posted 5 days ago • Updated 5 days ago

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Job Details

Skills

Analytical Skill
CDISC
Clinical Data Analysis
Clinical Research
Clinical Trials
Collaboration
Communication
Conflict Resolution
Data Management

Summary

We are looking for Clinical Programming for our client in West Chester, PA

Job Title: Clinical Programming

Job Location: West Chester, PA

Job Type: Contract

Job Description:

Pay Range: $70.94hr - $73.94hr

We are seeking an experienced Clinical Programmer to provide comprehensive analysis and reporting support at the study and program level.
The role involves developing ADaM specifications, generating analysis datasets and tables, listings, and figures, and ensuring compliance with regulatory standards and internal procedures.
The ideal candidate will have strong expertise in SAS programming, CDISC standards, and regulatory submissions within a pharmaceutical or clinical research environment.

Responsibilities:

Provide comprehensive programming support at the study, product, or program level.
Develop programs, ADaM specifications, and analysis datasets, tables, listings, and figures in compliance with regulatory requirements and departmental procedures.
Manage and deliver assignments with high quality and within established timelines.
Support CDISC-based electronic submissions.
Develop, debug, and enhance SAS programs to support quality control of safety and efficacy derived datasets and tables, listings, and figures.
Implement programming standards and ensure compliance with regulatory requirements across projects.
Communicate project status and resource gaps to management.
Standardize deliverables including datasets and tables, listings, and figures across study projects within therapeutic areas.
Identify and recommend process improvement opportunities.
Proactively communicate issues impacting programming deliverables with Statistics and Data Management teams.

Requirement/Must Have:

Strong proficiency in SAS programming for analysis datasets and reporting.
Expert knowledge of CDISC standards including SDTM and ADaM and related implementation guides.
Experience producing analysis datasets, tables, listings, and figures and electronic submission components.
Understanding of clinical trials, drug development processes, and industry standards.
Knowledge of statistical concepts used in clinical data analysis and submissions.
Ability to work independently and collaboratively within a team environment.
Strong written and verbal communication skills.

Experience:

Bachelor s degree with significant professional experience as a programmer in a pharmaceutical or clinical research setting.
Master s degree with professional experience as a programmer in a pharmaceutical or clinical research setting.
Experience supporting regulatory submissions and CDISC-based electronic submissions.

Should Have:

Experience with validation and compliance tools.
Knowledge of bioresearch monitoring inspections and integrated summary analyses.
Advanced knowledge of regulatory guidelines related to drug development across therapeutic areas.

Skills:

Advanced SAS programming and problem resolution.
CDISC-based electronic submission including ADaM dataset and reporting development.
Statistical analysis support for efficacy and safety data.
Regulatory compliance and industry standards knowledge.
Analytical thinking and problem-solving.
Stakeholder communication and collaboration.

Qualification And Education:

Bachelor s or Master s degree in Science, Statistics, Information Technology, or a related field.
Equivalent combination of education and relevant work experience may be considered.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: PA_CLPG_0220
Posted 5 days ago

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Clinical Programming

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Job Details

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