Sr. Statistical Programmer

Responsibilities

• Ensures statistical deliverables and study datasets are programmed and validated according to regulatory agency standards.
• Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or similar quality tools.
• Maintains an understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology.
• Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services.
• Supports collaboration with Data Management to facilitate SDTM development.
• Develops programming efficiencies (local macros) to ensure efficient programming work.
• Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics.
• Develops specification documents for datasets and other supporting documents (define.xml, annotated CRFs, reviewer's guides).
• Develops programming efficiencies (global macros) to ensure consistent and efficient work across studies.
• Tracks and escalates concerns related to changes in service scope.
• Mentors junior statistical programmers.

Requirements

• Bachelor's or master's degree or international equivalent in Biostatistics, Statistics, or programming-related field (5+ years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead preferred).
• Advanced SAS programming skills including SQL and macro development.
• Good knowledge and application of CDISC standards for SDTM and ADaM.
• Experience with Pinnacle21 and writing reviewer's guides.
• Basic understanding of standard statistical methodologies.
• Prior experience in ophthalmology is preferred.
• Strong technical and programming logic skills.
• A successful history of cross-functional collaboration.
• Sound knowledge of all relevant regulations and guidelines.
• Excellent verbal and written communication skills.
• Good planning and organizational skills with the ability to adapt and adjust to changing priorities.
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment.
• A strong interest in developing expertise in ophthalmology.