Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria
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About Dialpad Dialpad is the AI platform for customer experience, built to resolve customer problems in real time across voice and digital. Our AI agents learn from your best human agents and improve with every interaction, helping organizations understand their customers, deliver better experiences, increase operational efficiencies, and build a lasting competitive advantage. Unlike legacy systems built to route and answer, or standalone agentic bot vendors built to deflect, Dialpad was built to resolve. Our AI agents and human agents operate on a single platform with shared context, allowing Agentic AI to resolve issues, advance deals, and eliminate busywork through automation while seamlessly handing conversations to humans when needed, with full context preserved. Market-leading brands, including Randstad, Motorola Solutions, Netflix, the San Diego Padres, the Colorado Rockies Baseba
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If you’re excited about this role and possess the fundamental traits, drive, and strong ambition we seek, but your experience doesn’t meet every qualification, we encourage you to apply
Department · Professional Services

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Dialpad
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