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About the role
Key responsibilities & impact- Review submission-ready ADaM datasets, tables, figures, listings and submission packages
- Provide expertise in designing, developing and quality-controlling SAS programs for accessing, extracting, transforming, reviewing, analyzing and submitting clinical data
- Collaborate with study teams on data structures and specifications for ADaM datasets, tables, figures, listings and analysis submission content
- Ensure clinical data quality, accuracy and submission readiness according to regulatory requirements, including SDTM, ADaM, tables, figures, listings and define.xml
- Lead pooled and exploratory analyses with Statistics TA leads, study statisticians and clinical programming teams
- Lead in-house specification and delivery of ISS and ISE datasets and associated outputs when not provided by CROs
- Lead design and implementation of complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format
- Lead development of global tools to increase Statistical Programming group efficiency and capacity
- Plan and execute activities with clinical study teams to meet project timelines and deliver high-quality outputs
- Collaborate with CR&D staff on data analysis requests
- Perform additional statistical analyses supporting regulatory responses, integrated safety and efficacy summaries, 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 either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment
- Indepth understanding of clinical programming and/or statistical programming processes and standards
- Extensive experience with statistical programming using the SAS software, including development and use of SAS Macros
- Strong programming and problem-solving skills
- Good hands-on experience in R Programming is mandatory
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
- Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent)
- Proven 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