R&D Programmer III
R&D Programmer III
Posted on :
20-08-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-08-2025
Job Description
Description:
**This is a fully remote position for a Clinical Programmer 2 - Manager Level (SDTM)
US Based Candidate **
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
Major duties and responsibilities:
Responsible to define case report forms (CRFs) specifications in accordance with SDTM guideline and Teva standards and leads the cross functional review and approval process.
Responsible to define external (non CRF) data specifications in accordance with Biometrics standards
Responsible to define data flow and to ensure that study databases meet Teva requirements by performing User Acceptance Testing (UAT)
Responsible to perform supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
Responsible to perform data handling activities on an ongoing basis to ensure accuracy reliability integrity consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock.
Responsible to program SAS or SQL based clinical and operational listings and reports
Responsible to follow Clinical Programming processes and perform programming activities related to clinical external and operational data receipt and reporting to ensure the data meets Teva requirements and is reported with highest quality to all stakeholders
Develop positive partnerships with CROs and ensure a high standard of deliverables is maintained
Has a good understanding of SAS macros programs reporting tools infrastructure and has programming skills to develop new features programs and macros
Serves as the focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
Supports collaboration communication coordination and prioritization within the department working in conjunction with Data Management Lead.
Thorough understanding of Clinical data SDTM IG and Pinnacle 21
Education and Knowledge Requirements:
Bachelor s or higher degree in science or technology or equivalent combination of education and related work experience
5 years for Sr Programming Lead professional experience.
Strong and effective oral and written communication skills and interpersonal skills
Ability to manage multiple projects independently
Ability to work in a virtual global and multi-cultural environment High level of SAS software knowledge
Vast knowledge of CDISC standards
Detail oriented
US Based Candidate **
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
Major duties and responsibilities:
Responsible to define case report forms (CRFs) specifications in accordance with SDTM guideline and Teva standards and leads the cross functional review and approval process.
Responsible to define external (non CRF) data specifications in accordance with Biometrics standards
Responsible to define data flow and to ensure that study databases meet Teva requirements by performing User Acceptance Testing (UAT)
Responsible to perform supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
Responsible to perform data handling activities on an ongoing basis to ensure accuracy reliability integrity consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock.
Responsible to program SAS or SQL based clinical and operational listings and reports
Responsible to follow Clinical Programming processes and perform programming activities related to clinical external and operational data receipt and reporting to ensure the data meets Teva requirements and is reported with highest quality to all stakeholders
Develop positive partnerships with CROs and ensure a high standard of deliverables is maintained
Has a good understanding of SAS macros programs reporting tools infrastructure and has programming skills to develop new features programs and macros
Serves as the focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
Supports collaboration communication coordination and prioritization within the department working in conjunction with Data Management Lead.
Thorough understanding of Clinical data SDTM IG and Pinnacle 21
Education and Knowledge Requirements:
Bachelor s or higher degree in science or technology or equivalent combination of education and related work experience
5 years for Sr Programming Lead professional experience.
Strong and effective oral and written communication skills and interpersonal skills
Ability to manage multiple projects independently
Ability to work in a virtual global and multi-cultural environment High level of SAS software knowledge
Vast knowledge of CDISC standards
Detail oriented
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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