Senior Statistical Programmer

Responsibilities

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables and improving the efficiency and productivity of statistical programming work.
• Lead assigned projects by applying project management skills and statistical programming techniques to achieve on-time delivery with quality and maintain client trust.
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company SOPs and project-specific requirements.
• Perform quality control (QC) reviews of documents prepared by others.
• Program and validate SDTM and ADaM datasets following approved specifications for CSRs, ISS, and ISE.
• Perform CDISC standard-compliant checks on SDTM and ADaM datasets.
• Generate, review, and resolve Pinnacle 21 validation issues.
• Perform additional QC checks on these deliverables using company WI QC checklists.
• Perform overall quality/consistency review of statistical tables, listings, and figures (TLGs) before delivering them to the internal team or the client.
• Create SDTM and ADaM define.xml files and perform QC reviews of these files prepared by others.
• Participate in and/or lead programming teams in support of product regulatory submission-related activities.
• Learn and maintain expertise in the use of utilities and macros developed for the Statistical Programmers; develop new macros and utilities.
• Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
• Complete job-required and project-specific training; comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.
• Document data and programming information in accordance with corporate SOPs and guidelines; archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.

Qualifications

• A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, or Computer Sciences, with at least four years’ experience in clinical trial statistical programming.
• A Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming.