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, Sponsors, and SOPs.
• Assesses study datasets and resolves deviations from CDISC using Pinnacle21 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) as detailed in SOPs.
• 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.

Requirements :