Senior Statistical Programmer

Statistical ProgrammerResponsibilities:Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies.Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality toolsMaintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmologyProvides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM developmentDevelops programming efficiencies (eg, local macros) to ensure efficient programming workSupports the development and rollout of new innovations, standards, processes, and programming efficiencies within BiostatisticsDevelops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer's guides)Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studiesLeads and manages statistical programming priorities and task assignments for clinical studies and submissionsTracks and escalates concerns related to changes in scope of servicesMentors junior statistical programmersRequirements:Bachelor's or master's degree or international equivalent in Biostatistics, Statistics, or programming-related field5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferredA high level of SAS programming skills including SQL and macro developmentGood knowledge and application of CDISC standards for SDTM and ADaMExperience with Pinnacle21 and writing reviewer's guides is a plusBasic understanding of standard statistical methodologies is expectedExperience with ophthalmology is preferredGood understanding of statistical programming topics in medical product developmentExcellent technical and programming logic skillsA successful history of cross-functional collaborationSound knowledge of all relevant regulations and guidelinesExcellent verbal and written communication skillsGood planning and organizational skills with the ability to adapt and adjust to changing prioritiesAbility to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environmentA strong interest in developing expertise in ophthalmology