Jobs in Saint Denis, United States

Job Title: Clinical Programmer 2 - Manager Level (SDTM)
Job Duration: 12+ months
Location: Remote(Israel)
Pay: ₪138.45 - ₪199.95 ILS/hr ($35 - $51/hr) (based on experience)

Shift Schedule: 8:00am - 5:00 pm Sunday - Thursday Israel time

Core essential:

• Minimal Bachelor’s degree in any field
• Minimal 5 years experience with Clinical data, SDTM IG, and Pinnacle 21.

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:

• Provides input for Budget Planning
• Likely to oversee contingent workers and/or vendors; Likely to provide training to others
• Primarily works at the project level
• Delivers assignments with quality and within timelines
• Contributes strategy under moderate supervision
• 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
• Has good knowledge and understanding of the statistical models in efficacy data analysis
• Responsible for the standardization of Clinical Programming deliverables within a project
• 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.

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:

• Contributes to strategy under moderate supervision
• Tackles difficult problems; identifies solutions and recommends action to management
• Influences communication toward common understanding and actionable results; contributes to process and development
• Ability to effectively work in a global environment
• 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 client 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 client 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 client 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