Senior Statistical Programmer (FSP - Permanent Homebased)
On-siteBratislava, Bratislava Region, Slovakia
Job Summary
Review datasets in submission-ready standard format (ADaM), tables, figures, listings, and submission packages. Design, develop, and quality control SAS programs to access, extract, transform, review, analyze, and submit clinical data for all requested analyses. Collaborate with study teams to define data structures for ad hoc and study deliverables while ensuring clinical data accuracy per regulatory authorities. Lead pooled and exploratory analyses, manage legacy data collection, and oversee in-house ISS and ISE dataset delivery. Develop complex SAS programs for CDISC ADaM reporting and create global tools to enhance Statistical Programming group efficiency. Support regulatory agency responses, integrated safety and efficacy summaries, and clinical trial planning via exploratory analyses.
Required Qualifications
- 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 using SAS Software
- In-depth understanding of clinical programming and/or statistical programming processes and standards
- In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
- Strong programming and problem-solving skills
- 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 both independently or in a team setting, and to meet set goals by managing own timelines
- Experience in working in cross-functional, multicultural and international clinical trial teams
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