Programming Manager, Clinical Programming

Role: Clinical Data Standards Specialist focusing on SDTM data modeling for biopharma clinical trials. Objectives: develop, implement, and maintain SDTM standards aligned with CDISC and regulatory requirements, ensuring data quality and consistency across studies. Responsibilities: create SDTM standards supporting scientific needs, review study data collection tools (eCRFs), guide data mapping, ensure compliance of SDTM datasets for submissions, develop QC processes, support digital solutions and data visualization tools, and promote knowledge sharing within the organization. Requirements: Bachelor's in Statistics, Life Sciences, or Computer Science; 3-5 years in pharma/biotech; proficiency in SAS and understanding of SDTM data model; experience working in global clinical trial environments; excellent communication skills. Preferred: Master’s degree and experience with industry standards and regulatory guidelines. HighValue: expertise in SDTM standards, CDISC compliance, and clinical data management, supporting the development of antibody therapeutics in oncology and serious diseases; involvement in data exchange, quality control, and support for regulatory submissions. WorkSetup: flexible work arrangements with 20-40% remote work; no travel specified.