Clinical Programmer

Stefanini Group is hiring!

Stefanini is looking for Clinical Programmer (Remote)

For quick Apply, please reach out to Rachit Rastogi - call: / email:

Work Hours: M-F (40 hours)

Work Location: Remote

Shift: Morning - US time zone 8 hours/day - preferably East Coast



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.

Responsible to define case report forms (CRFs) specifications in accordance with SDTM guideline and clients standards and leads the cross functional review and approval process.Responsible to define external (non CRF) data specifications in accordance with Biometrics standardsResponsible to define data flow and to ensure that study databases meet clients 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 timelinesResponsible 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 reportsResponsible to follow Clinical Programming processes and perform programming activities related to clinical, external, and operational data receipt and reporting to ensure the data meets clients requirements and is reported with highest quality to all stakeholdersDevelop positive partnerships with CROs and ensure a high standard of deliverables is maintainedHas a good understanding of SAS macros, programs, reporting tools, infrastructure and has programming skills to develop new features, programs, and macrosServes 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

Bachelor's or higher degree in science or technology or equivalent combination of education and related work experience5+ years for Sr Programming Lead professional experience.Strong and effective oral and written communication skills and interpersonal skillsAbility to manage multiple projects independentlyAbility to work in a virtual, global, and multi-cultural environment High level of SAS software knowledgeVast knowledge of CDISC standardsDetail 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 four hundred 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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