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Role Overview We are seeking an experienced Senior Statistical Programmer to support regulatory submission activities within the Submissions Group (Center of Excellence). The role requires strong expertise in CDISC standards, ISS preparation, and eCRT deliverables, along with advanced SAS programming skills. The ideal candidate will have in-depth knowledge of clinical trial data standards and experience supporting global regulatory submissions. Key Responsibilities - Lead and execute programming activities for regulatory submissions - Develop and validate submission deliverables including: - ISS / ISE outputs - ECRT packages (aCRF, define.xml, CSDRG) - Perform high-quality SAS programming for SDTM, ADaM, and TFLs. - Ensure compliance with CDISC standards and regulatory guidelines. - Support BIMO-related programming activities (if applicable). - Review and QC programming outputs to ensure accuracy and submission readiness. - Interpret complex clinical trial data and resolve data-related queries. - Work independently and lead programming assignments within timelines. - Document key decisions and maintain submission documentation. Required Qualifications & Skills - Robust SAS programming expertise. - Extensive clinical trial experience (Phase IIII preferred). - Strong knowledge of CDISC standards (SDTM, ADaM). - Hands-on experience with: - ISS/ISE preparation - ECRT packages (aCRF, define.xml, CSDRG) - Solid understanding of regulatory submission processes. - Ability to lead projects and work independently. - Strong analytical and problem-solving skills. - Excellent communication skills. Preferred Qualifications - P21 experience. - BIMO submission experience. - R programming knowledge. - Prior experience in a Submissions or Regulatory Center of Excellence. Candidate Profile - Detail-oriented and quality-driven. - Strong documentation and compliance mindset. - Capable of managing multiple priorities in a submission-driven environment. Apply today *Phastar is com .
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