Statistical Programming Consultant

Statistical Programming Consultant (Principal Statistical Programmer) Office-based, 4 days/week – [Malvern PA] 6+Month Contract | 40 hrs/week Client Overview Our client is a rapidly growing ophthalmology biotechnology company advancing a pipeline of innovative therapies to address rare and underserved ocular disorders. With a focus on gene and cell therapies, biologics, and breakthrough treatments, they are committed to transforming global healthcare. The Role We are seeking an experienced Principal Statistical Programmer to join the client team. This consultant will work closely with the Director of Biostatistics, internal teams, and CROs to deliver high-quality statistical programming support for clinical trials, regulatory submissions, and cross-study integration. Key Responsibilities • Develop and validate SDTM and ADaM datasets in compliance with CDISC standards. • Create and review tables, listings, and figures (TLFs) for clinical trial reporting. • Write programming specifications and ensure accurate, reproducible analyses. • Support statistical analysis plans, including mock-ups of displays and methodology descriptions. • Collaborate with CROs to ensure timely, secure, and accurate data delivery. • Assist in preparation of submission documents and electronic case report forms (eCRTs). • Proactively identify risks, propose solutions, and support compliance with regulatory requirements. • Contribute to SOP development, departmental training, and cross-functional meetings. Qualifications • BS/MS in Statistics, Computer Science, Mathematics, Life Sciences, or related field. • 5+ years of SAS programming experience in a clinical trial environment (Pharma/Biotech required). • Strong working knowledge of CDISC (SDTM & ADaM) standards and regulatory submission processes. • Proficiency in SAS (Base, Stat, Macro, Graph); knowledge of R and/or Python a plus. • Solid understanding of statistical concepts and clinical trial principles. • Experience leading programming for multiple studies or submissions preferred. • Excellent communication, organization, and problem-solving skills.