Statistical Programmer II

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

📋 Description

• Create and assess SDTM and ADaM dataset specifications, annotated CRFs, define.xml, reviewer’s guides, and related documentation.

• Program and verify SDTM and ADaM datasets.

• Conduct CDISC conformance checks and resolve any findings.

• Develop SAS programs for statistical output reports in accordance with the SAP and TLG mock-up shells.

• Offer programming support for Clinical Study Reports, integrated safety and efficacy analyses, regulatory safety reports, ad-hoc requests, and exploratory analyses.

• Create and maintain SAS programs for database integrity assessments and ongoing data cleansing.

• Reconcile CRF and non-CRF data while performing integrity checks on non-CRF data.

• Produce data listings, summary tables, graphs, and Patient Profiles.

• Document data and programming details in line with SOPs and WIs.

• Ensure audit readiness and meet specified statistical programming performance indicators.

• Stay updated on industry standards and regulatory requirements.

• Develop and offer expertise in additional programming and system administration areas as needed.

⛳️ Requirements

• Master’s or Ph.D. degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences.

• SAS certification as Base, Advanced, and Clinical Trials Programmers is strongly preferred.

• Experience or exposure to clinical trial statistical programming and/or data analysis is advantageous.

• Up-to-date knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements.

• Familiarity with sponsor-specific requirements in clinical trials when applicable.

• Adherence to Everest company-specific and clinical trial sponsor-specific training requirements.

🏝️ Benefits

• Equal opportunity and accommodations for candidates with disabilities.

• Remote or hybrid work options available for the Taiwan location.