Senior Statistical Programmer

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

📋 Description

• Spearhead initiatives to address daily work-related challenges, ensuring the quality of deliverables while enhancing the efficiency and productivity of statistical programming tasks.

• Oversee assigned projects by leveraging project management expertise and statistical programming methodologies; ensure timely delivery of quality outputs, fostering client trust and repeat engagements.

• 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 the company's or client’s Standard Operating Procedures (SOPs) and project-specific criteria.

• Conduct quality control (QC) reviews of documents prepared by colleagues.

• Program and validate SDTM and ADaM datasets based on approved dataset specifications for CSRs, ISS, and ISE.

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

• Generate, review, and address Pinnacle 21 validation concerns.

• Conduct additional QC assessments on these deliverables using company Working Instruction (WI) QC checklists.

• Perform comprehensive quality and consistency reviews of statistical Tables, Listings, and Graphs (TLGs) prior to submission to the internal team or the client.

• Create SDTM and ADaM define.xml files.

• Perform QC reviews of these files prepared by others.

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

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

• Innovate new macros and utilities.

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

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

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

• Document data and programming information in alignment with corporate SOPs and guidelines.

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

⛳️ Requirements

• A Master’s or Ph.D. degree 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 with at least six years of experience in clinical trial statistical programming.

🏝️ Benefits

• Work from Home policy