Senior Clinical Programmer, SDTM
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Clinical Programmer managing trial set-up documentation and creating detailed technical specifications for SDTM datasets. Overseeing clinical programming deliverables and ensuring compliance with industry standards.
Responsibilities:
- Review and provide input into all trial set-up documentation
- Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.
- Creation of Data Review Model (DRM) based on current Client standards and SDTM datasets based on current SDTM standards
- Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review
- QC of all clinical programming deliverables
- Perform unblinding, data-cut activities for planned reporting milestones and database locks
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed
- Support the development of standards and drive implementation within the organization
Requirements:
- Minimum 4+ years of relevant experience in SDTM Clinical Programming
- Good knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
- Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
- Advanced knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus
- Demonstrated understanding of current industry standards for submission of clinical trial data
- Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects
- Ability to communicate with cross-functional teams, and business partners and gather feedback for study specifications and/or data issues.
Benefits:
- Health insurance
- Professional development
- Flexible work arrangements
Similar Jobs
Staff Applications Developer – Mendix
Mendix Dev Tech Lead developing and maintaining applications using Mendix platform at Dexcom. Collaborating with cross-functional teams to optimize systems and enhance user experiences.
Senior Mobile Developer
Senior Mobile Architect leading design, architecture, and delivery of mobile applications at Reply. Working fully remote from Brazil on hybrid app development projects.
Team Lead Software Development, Benefits Platform
Lead Software Engineer developing and managing a scalable Multi-Benefit platform. Seeking an experienced technical leader to drive architectural projects and build a cross-functional team.
Developer Workflow Management
Developer in Workflow Management for coeo integrating and automating workflows in IKAROS software while modeling processes and optimizing existing functionalities.
C# Developer
C# Developer responsible for developing innovative applications for coeo's web services. Work includes APIs, backend services, and optimizing database designs.
C# Developer – AI Focus
C# Developer focusing on AI to develop intelligent software solutions for data-driven processes. Collaborating closely with departments for requirements analysis and creating AI-based solutions.
Senior Product Developer
Full Stack Developer focusing on AWS product development at Gainwell. Supporting innovative technologies and solutions in health and human services.
Service Now Integration Developer – VA EHR
ServiceNow Integration Developer contributing technical expertise to large-scale health IT programs. Collaborating across teams to maintain operational continuity and support EHR integration efforts.
Developer – OutSystems
Desenvolvedor (OutSystems) na Hitss criando soluções tecnológicas e evoluindo aplicações em ambiente ágil. Participar do levantamento de requisitos e garantir a performance e escalabilidade das soluções.
Mobile Engineer
Mobile Engineer developing Android and iOS applications for a leading nearshore staff augmentation provider in Latin America. Collaborate on high-impact projects with top American companies.
Engineer / Developer – Freelance
Freelance Engineer/Developer at SPACE44 building scalable applications and cloud environments for diverse client projects. Join an expert community of engineers across various technical domains.
Flutter Developer III – Franchisee Backoffice
Flutter Developer creating high complexity mobile solutions for Grupo Boticário. Contributing to multidisciplinary teams and ensuring technical quality in digital products.
Flutter Developer – Specialist I
Flutter developer at Grupo Boticário developing mobile applications for customer management and sales. Collaborating with design and backend teams on technical solutions and improving code quality.
Mobile App Developer
Mobile App Developer building scalable iOS and Android applications for a rapidly growing AI startup. Collaborating with engineers to enhance a leading global mobile app platform.
Playable Ads Developer
Playable Ads Developer tasked with creating engaging interactive ads for Voodoo's mobile games. Collaborating with diverse teams to optimize user experience and performance.
Desenvolvedor Oracle OFS/OIC – Sênior
Develop Oracle Field Service solutions in critical operational environments, maintaining and evolving integrations and plugins. Participates in technical design, troubleshooting, and documentation processes.
Developer, XML, Data Integration
Developer working on XML-based data integrations for educational offerings at velpTEC. Focused on data structure modelling and automation for consistent information exchange.
Lead Mobile Engineer
Mobile Engineer Lead managing BeatStars’ mobile strategy while defining architecture and standards for the mobile practice. Writing production code and mentoring the mobile engineering team.
Application Developer I
Application Developer I providing application development support for business processes at Greenheck Group. Develop, modify, and maintain application software with day-to-day debugging and documentation tasks.
Web / WordPress Developer
Web/WordPress Developer focusing on WordPress-based CMS projects and integration. Collaborating with a team in a flexible, remote work environment.