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Senior Statistical Programmer 2
Worldwide Clinical Trials. Lead statistical programming activities across complex clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced SAS programming expertise, including SAS/Macro and Proc SQL, while ensuring compliance with CDISC standards and regulatory requirements. Proven ability to lead statistical programming activities and mentor cross-functional teams in a clinical research environment.
Highest-signal resume keywords
Advanced SAS Programming ExpertiseCDISC Standards KnowledgeRegulatory Submission PreparationStatistical Programming LeadershipMentoring and Training Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SAS ProgrammingSAS/MacroProc SQLCDISC SDTMCDISC ADaMStatistical ReportingDataset DevelopmentTFL PreparationQuality Management DocumentationAnalytical Skills
Soft Skills
Problem-Solving SkillsDetail-OrientedAbility to Manage Multiple Priorities
Industry Keywords
Clinical ResearchElectronic Data SubmissionsGlobal Regulatory RequirementsSubmission-Ready DocumentationStatistical Programming Activities
Tech Stack
Tools & technologiesSQL
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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