Sr. Statistical Programmer

Responsibilities

• 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 Pinnacle
  21 or other quality tools
• Maintains a basic 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 (eg, 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 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 studies
• Leads and manages statistical programming priorities and task assignments for clinical studies and submissions
• Tracks and escalates concerns related to changes in scope of services
• Mentors junior statistical programmers

• Bachelor s or master s degree or international equivalent in Biostatistics, Statistics, or programming-related field
• 5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred
• A high level of SAS programming skills including SQL and macro development
• Good knowledge and application of CDISC standards for SDTM and ADaM
• Experience with Pinnacle
  21 and writing reviewer s guides is a plus
• Basic understanding of standard statistical methodologies is expected
• Experience with ophthalmology is preferred
• Good understanding of statistical programming topics in medical product development
• Excellent 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