Clinical Programming

Parsippany, NJ, US • Posted 1 day ago • Updated 1 day ago

Contract W2

On-site

Depends on Experience

Fitment

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Job Details

Skills

Information Technology
Data Management
Database
Debugging
Documentation
FOCUS
CDISC

Summary

We are looking for Clinical Programming for our client in Parsippany, NJ

Job Title: Clinical Programming

Job Location: Parsippany, NJ

Job Type: Contract

Job Description:

Pay Range: $70.94hr - $73.94hr

The Clinical Programming Contractor is responsible for providing comprehensive programming support at the study and program level, with a focus on SDTM dataset development and regulatory-compliant submissions.
This role supports CDISC-based e-submissions and ensures that all deliverables comply with regulatory requirements, departmental SOPs, and industry standards.
The position requires strong SAS programming expertise, in-depth knowledge of SDTM standards and implementation guides, and experience working within pharmaceutical or clinical research environments.

Requirement/Must Have:

Bachelor s degree with 5 years, or Master s degree with 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
Strong proficiency in SAS programming for SDTM dataset creation and quality control.
Expert knowledge of CDISC standards and SDTM Implementation Guides.
Experience developing SDTM specifications and datasets compliant with regulatory requirements.
Experience supporting CDISC-based e-submissions including Define packages.
Proficiency with tools such as Pinnacle 21, XML, and MS Office.
Strong understanding of clinical trials, drug development processes, and database concepts used in clinical studies.
Ability to work independently and collaboratively within cross-functional teams.
Strong written and verbal communication skills.

Responsibilities:

Develop, debug, and enhance SAS programs to support SDTM dataset creation and quality control.
Create SDTM specifications and datasets in compliance with regulatory requirements and departmental SOPs.
Generate data review listings, operational reports, and other study-level outputs.
Support CDISC-based e-submissions including preparation of SDTM datasets and associated documentation.
Perform ongoing data handling activities to ensure data accuracy, integrity, consistency, and completeness prior to database lock.
Provide final datasets to clinical programming and statistics teams at key study milestones.
Support creation and review of case report forms and specifications aligned with SDTM guidelines.
Define and document external data sources and support functional review and approval processes.
Implement programming standards across projects and ensure regulatory compliance.
Communicate project status, risks, and resource gaps to management.
Proactively communicate issues impacting programming deliverables with Statistics and Data Management teams.

Should Have:

Advanced knowledge of government regulations such as CDISC and ICH related to drug development.
Strong knowledge of clinical data standards and regulatory submission requirements.
Experience across multiple therapeutic areas.
Demonstrated problem-solving skills with the ability to recommend actionable solutions.
Ability to influence communication toward common understanding and results.

Qualification And Education:

Bachelor s or Master s degree in Science, Statistics, Information Technology, or related field.
Relevant professional experience in clinical programming within pharmaceutical or clinical research environments required.

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: NJ_JSDA_0225
Posted 1 day ago

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Clinical Programming

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