Sr. Statistical Programmer

Job Description :

We're looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Use statistical programming software to develop datasets and tables, figures, and listings that comply with regulatory standards and support the analysis, reporting, interpretation, and publication of clinical trial data.

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 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).
• 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.
• Mentor's junior statistical programmers.

Requirements :