Principal Statistical Programmer - Europe

November 29

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Catalyst Clinical Research

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Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• Program routine and customized data displays including listings, tables, and graphics. • Write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. • Creation of safety and efficacy SAS datasets. • Creation of SDTM and/or ADaM specifications. • Creation of project specific macros and formats. • Creation of CDISC compliant DEFINE, SDRG, ADRG. • Serve as Statistical Programming subject matter expert (SME) as needed. • Performing data checks to ensure integrity and correctness of data displays. • Perform QC/validation of datasets, tables, listings, figures to verify output. • Establish, maintain, and strengthen professional working relationship with various stakeholders. • Represent department and company in project team and client meetings. • Ensure quality and integrity of data analysis and reporting. • Maintain awareness of project budgets and tasks, and communicate status to management. • Contribute to the development of functional-level standards, tools, and templates. • Interact across operational areas and with sponsor representatives as needed.

Requirements

• A minimum of 7 years of relevant work experience. • Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. • Capable of conducting exploratory statistical analyses using statistical software packages. • Experience developing custom SAS programs. • Experience with P21 reporting and DEFINE, SDRG, ADRG development. • Creation of annotated CRFs. • Previous experience in pharmaceutical research or CRO setting. • Base or Advance SAS certification preferred. • Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred).