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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in SAS programming for clinical data analysis, including the design and quality control of ADaM datasets and compliance with CDISC standards. Proven ability to lead programming activities and collaborate effectively within cross-functional clinical trial teams.
Highest-signal resume keywords
SAS ProgrammingADaM Dataset DevelopmentCDISC Standards KnowledgeStatistical AnalysisLeadership in Clinical Programming
ATS Keywords
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Hard Skills
SASSAS MacrosR ProgrammingStatistical ProgrammingClinical ProgrammingData AnalysisQuality ControlData Structure DesignSubmission Package PreparationStatistical Analysis Techniques
Soft Skills
Problem-SolvingCollaborationTime ManagementIndependent WorkTeamwork
Industry Keywords
Clinical TrialsCROPharmaceuticalSDTMCDASHIntegrated SummariesExploratory AnalysesRegulatory SubmissionsMulticultural TeamsClinical Study Teams
About the role
Key responsibilities & impact- Review submission-ready ADaM datasets, tables, figures, listings, and submission packages
- Provide expertise in the design, development, and quality control of SAS programs for accessing, extracting, transforming, reviewing, analyzing, and submitting clinical data
- Collaborate with study teams to design data structures and specifications for ADaM datasets, tables, figures, listings, and analysis submission content
- Ensure the quality, accuracy, and submission readiness of clinical data, including SDTM, ADaM, tables, figures, listings, and define.xml
- Lead and oversee pooled and exploratory analyses with Statistics TA leads, study statisticians, clinical programming teams, and legacy data teams
- Lead and oversee in-house specification and delivery of ISS and ISE datasets and associated tables, figures, and listings when not provided by CROs
- Lead and oversee complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format
- Lead and oversee global tools to increase the efficiency and capacity of the Statistical Programming group
- Plan and execute activities with clinical study teams to meet project timelines and deliver high-quality outputs
- Collaborate with CR&D staff regarding data analysis requests
- Perform additional statistical analyses supporting regulatory agency responses, integrated summaries of safety and efficacy, publications, presentations, and clinical trial planning and reporting
Requirements
What you’ll need- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
- At least 5+ years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment
- In-depth understanding of clinical programming and/or statistical programming processes and standards
- Extensive experience with statistical programming using SAS, including development and use of SAS Macros
- Strong programming and problem-solving skills
- Good hands-on experience in R Programming is advantageous
- Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM
- Proven experience leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities, or equivalent
- Ability to work effectively independently or in a team setting and meet set goals by managing own timelines
- Experience working in cross-functional, multicultural, and international clinical trial teams
Benefits
Comp & perks- Diversity, inclusion, and belonging culture
- Opportunity to work with talented employees worldwide
- Opportunity to contribute to innovative healthcare and clinical research outcomes