Clinical Programmer

Stefanini Group is hiring!

Stefanini is looking for Clinical Programmer - (Israel Based - Fully Remote)

For quick apply, please reach out to Ranjit Kumar - call: / Email:



**This is a fully remote position for a Clinical Programmer - Israel Based - Fully Remote **

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



Core essential:Minimal Bachelor's degree in any fieldMinimal 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 PlanningLikely to oversee contingent workers and/or vendors; Likely to provide training to othersPrimarily works at the project levelDelivers assignments with quality and within timelinesContributes strategy under moderate supervisionProvides 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 datasetsHas good knowledge and understanding of the statistical models in efficacy data analysisResponsible for the standardization of Clinical Programming deliverables within a projectExtends 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 programmerExperience 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:Contributes to strategy under moderate supervisionTackles difficult problems; identifies solutions and recommends action to managementInfluences communication toward common understanding and actionable results; contributes to process and developmentAbility to effectively work in a global environmentAbility 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 skillsAbility 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.



Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.



Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.



About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.



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