Senior Statistical Programmer 2
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Job Description
Senior Statistical Programmer leading SAS and CDISC clinical trial programming for Worldwide Clinical Trials, a global clinical research organization. Delivering regulatory-ready datasets, analyses, and submission documentation for complex studies.
Responsibilities:
- Lead statistical programming activities across complex clinical studies
- Ensure high-quality delivery, effective resource planning, and alignment with project scope and budgets
- Develop, test, validate, and review SAS programs
- Generate CDISC SDTM and ADaM datasets, tables, figures, listings, and other clinical study deliverables
- Provide expert guidance on clinical database specifications, data transfer requirements, dataset specifications, and statistical reporting outputs
- Serve as a subject matter expert in CDISC standards, electronic data submissions, and global regulatory requirements
- Oversee preparation and review of submission-ready documentation, including annotated CRFs, define.xml packages, reviewer guides, and analysis metadata
- Drive continuous improvement through programming standards, SAS macros, SOPs, templates, and quality management documentation
- Mentor, coach, and train Statistical Programmers, Biostatisticians, Clinical Data Managers, and other stakeholders
- Support proposal reviews, budget assessments, bid defense activities, audits, inspections, and sponsor interactions
- Ensure compliance with quality and regulatory requirements
Requirements:
- Bachelor's degree or equivalent education
- At least 6 years of relevant statistical programming experience within a clinical research environment
- Advanced SAS programming expertise, including SAS/Macro, Proc Report, ODS, BASE SAS, SAS/Graph, Proc SQL, and SAS/STAT
- Experience leading programming activities for complex clinical studies and providing technical leadership to project teams
- Strong knowledge of CDISC standards, including SDTM and ADaM
- Experience preparing regulatory submission packages and supporting health authority requirements
- Experience developing and reviewing clinical study datasets, TFLs, specifications, reviewer guides, and related submission documentation
- Strong analytical, problem-solving, and detail-oriented skills
- Ability to manage multiple priorities and deliver high-quality results
- Ability to mentor, train, and support colleagues and cross-functional partners
Benefits:
- Collaborative and inclusive environment
- Growth and career development opportunities
- Learning, mentoring, and training opportunities
- Opportunity to contribute to innovation and continuous improvement
- Global team collaboration
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