R&D Programmer III
R&D Programmer III
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Salary Not Disclosed
1 Vacancy
Job Description
Please list the pay rate at the top of the resume.
Pay: Confidential - Confidential/hr based on experience
Bill: Confidential - Confidential/hr based on experience
Shift Schedule: Morning - US time zone 8 hours/day preferably East Coast
Temp to Perm: Not at this time
Core essential:
1. Minimal Bachelor s degree in any field
2. Minimal 5 years experience with Clinical data SDTM IG and Pinnacle 21.
Screenings:
1. Basic Background
2. 11 Panel Drug Fentanyl
Position Summary:
The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Manager leads and manages completed projects that involve global tasks cross functional teams or outsourcing resources. The role may require providing input to design and analysis and report the results of clinical trials including programming rules and mocked T/L/G. In addition providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
Travel Requirements: Limited as job tasks are required
Essential Duties & Responsibilities:
1. Provides input for Budget Planning
2. Likely to oversee contingent workers and/or vendors; Likely to provide training to others
3. Primarily works at the project level
4. Delivers assignments with quality and within timelines
5. Contributes strategy under moderate supervision
6. Provides strong programming support to CDISC based e-submission. Develop review and/or perform validation of generic macros. Develop debug and enhance SAS programs to support quality control of safety or efficacy derived datasets
7. Has good knowledge and understanding of the statistical models in efficacy data analysis
8. Responsible for the standardization of Clinical Programming deliverables within a project
9. Extends existing or develops new clinical programming methods to solve complex problems
Position Requirements:
Education Required: Bachelor s Degree/ Master s Degree/ PhD in Science Statistics Information Technology or equivalent combination of education and related work experience.
Experience Required: Bachelor s 5 years or Master s 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
Experience Preferred: Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
Specialized or Technical Knowledge Licenses Certifications needed:
Functional Knowledge:
Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis.
Company/Industry Related Knowledge: Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.
Job-Specific Competencies:
1. Contributes to strategy under moderate supervision
2. Tackles difficult problems; identifies solutions and recommends action to management
3. Influences communication toward common understanding and actionable results; contributes to process and development
4. Ability to effectively work in a global environment
5. Ability to effectively interact with and influence others without direct reporting relationships
Additional Details
- Managers Requested Bill Rate : (No Value)
- Shore Options Available for this Position : Onshore Only
- Critical Position : No
- Is this an IT position : No
- Does the position allow for the worker to be virtual/remote : Yes
- Shift Type : Morning
- White/ Blue Collar Worker : White Collar
- Is this request considered Top Management (Level 3 and up) and management support : No
- Will this position have access to highly sensitive information : No
- Will this position have access to sensitive assets (controlled substances narcotics etc.) : No
- Is this a Purchasing/procurement position : No
- Project Code : RS-.1150
Employment Type
Full-time
Key Skills
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