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Responsibilities
We’re looking for a highly skilled professional to join our team and contribute to complex clinical trial programming and statistical analysis activities.KEY SKILLS & EXPERTISEAdvanced SAS Programming (SAS/Base, SAS/STAT, SAS Macros, SAS/Graph; development and maintenance of SAS utilities and macros)Clinical Trial Programming (statistical analysis and programming for clinical trials; Tables, Listings & Figures (TFLs); program validation and QC; SAP review and implementation; data cleaning and integrity checks)CDISC Expertise (expert knowledge of CDISC SDTM & ADaM; SDTM/ADaM specifications, programming & validation; aCRF/specification review; Define.xml development; Study Data Reviewer's Guide (SDRG); Analysis Data Reviewer's Guide (ADRG); Pinnacle 21 review and compliance)Regulatory & Clinical Knowledge (clinical trial design and analysis; FDA/CFR requirements; ICH/GCP guidelines; strong understanding of clinical data and regulatory submission requirements)Leadership & Collaboration (lead or oversee programming activities for complex projects; mentor and provide guidance to junior programmers; collaborate with Clinical Operations, Data Management, Biostatistics and Project Management; communicate technical concepts clearly to non-statistical stakeholders; manage priorities, timelines, quality and project deliverables)Preferred Certifications: SAS Base | Advanced SAS | SAS Clinical TrialsWho Should Apply? If you are a Senior/Principal Statistical Programmer with strong SAS programming experience and hands-on expertise in SDTM, ADaM, TFLs and clinical trial reporting, this could be a great opportunity to showcase your expertise on a high-impact project.
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