Senior Statistical Programmer

Job TitleResponsibilities:Ensure departmental or functional training plans in place and appropriatePerform vendor qualifications regarding statistical programming functions and manage CRO programming issues and manage activities to ensure on time deliverables within budgetGenerate, validate, and/or review SDTM domains and ADaM datasets and associated specificationsGenerate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publicationsGenerate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)Maintain complete and auditable documentation of all programming activitiesManage datasets and output across SAS programs, studies, and indications to ensure consistencyManage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requestsManage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation proceduresDevelop and/or maintain departmental procedures and standardsReview CRFs, edit check specifications, and table, figure, and listing mock-upsManage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documentsAssist in validation of SAS per 21 CFR Part 11Train and mentor new members and programmers; supervise contract programmers, as neededRequirements:Bachelor's degree in Statistics, Mathematics, Computer Science or a related field requiredMinimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmerPrior experience overseeing statistical programming contractors requiredCompound oversight experience highly preferredExtensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODSExperience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferredDemonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelineseCTD NDA submission experience is a must.