Senior Statistical Programmer

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

📋 Description

• Design and validate edit check programs utilizing standard validation methodologies.

• Create SAS programs to transform data from Electronic Data Capture (EDC) into protocol-specific SAS datasets.

• Examine and annotate Case Report Forms (CRFs) for SDTM mapping.

• Offer statistical programming assistance to produce ADaM datasets, tables, listings, and figures for individual studies (covering both safety and efficacy) as well as for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) studies.

• Leverage advanced knowledge of CDISC standards (SDTM and ADaM) across all deliverables.

• Execute P21 reports for both SDTM and ADaM datasets and analyze the findings.

• Create and validate SAS macros and format libraries.

• Ensure the integrity of client data and data exports.

• Develop documentation pertaining to the creation of customer-specific SAS datasets.

• Manage the SAS environment, including support for installation, updates, and maintenance.

• Review and endorse User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and operational procedure documents.

• Design and implement new CDM systems and enhancements to existing CDM systems.

• Comprehend, develop, and convey information regarding the creation of CDISC-compliant datasets.

• Support the Study Quality Representative in testing protocol-specific SAS conversion programs.

• Proactively oversee simultaneous activities within a study or project.

• Evaluate and assign target dates for project timelines in partnership with the manager.

• Comply with project target dates and inform relevant personnel, including the Project Manager, of any changes.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Statistics, or a related discipline — mandatory

• Over 8 years of SAS programming experience in the pharmaceutical or clinical research industry — mandatory

• At least 5 years of experience with CDISC standards, SQL, and relational databases — mandatory

• Minimum of 3 years of experience in database organization and data extraction for listings and reports — mandatory

🏝️ Benefits

• Competitive base salary

• Paid time off

• Comprehensive healthcare and retirement benefits