Senior Statistical Programmer

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the resolution of daily work-related challenges, ensuring the quality of deliverables while enhancing the efficiency and productivity of statistical programming tasks.

• Manage assigned projects by utilizing project management skills and statistical programming methodologies; ensure timely delivery of high-quality deliverables, fostering client trust and repeat engagement.

• Create SDTM and ADaM dataset specifications for Clinical Study Reports (CSRs), Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE) in accordance with company or client-specific Standard Operating Procedures (SOPs) and project requirements.

• Conduct quality control (QC) reviews of documents prepared by other team members.

• Program and validate SDTM and ADaM datasets in line with approved dataset specifications for CSRs, ISS, and ISE.

• Execute CDISC standard compliance checks on SDTM and ADaM datasets.

• Generate, assess, and address Pinnacle 21 validation issues.

• Carry out additional QC checks on deliverables using the company's Working Instruction (WI) QC checklists.

• Perform a comprehensive quality and consistency review of statistical TLGs prior to submission to the internal team or client.

• Develop SDTM and ADaM define.xml files.

• Conduct QC reviews of these files created by other personnel.

• Engage in or lead programming teams for activities related to product regulatory submissions.

• Acquire and maintain proficiency in the utilities and macros developed for Statistical Programmers.

• Create new macros and utilities.

• Program and execute QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.

• Complete necessary job-related and project-specific training.

• Adhere to relevant Everest and trial Sponsor’s Policies, SOPs, and WIs.

• Document data and programming details in accordance with corporate SOPs and guidelines.

• Archive clinical trial data (SDTM and ADaM datasets) and programming information following corporate archival SOPs and guidelines.

⛳️ Requirements

• A Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Sciences, with a minimum of four years of experience in clinical trial statistical programming.

• A Bachelor's degree in the aforementioned fields accompanied by at least six years of experience in clinical trial statistical programming.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.