Senior Principal Statistical Programmer

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Technically lead and project manage multiple clinical studies and their statistical and clinical programming deliverables • Represent Statistical Programming in Study Management Team and Clinical Development meetings • Assess resourcing needs and support project staffing • Review study-related documents including statistical analysis plans, case report forms, data management plans, database specifications, EDC data structures, and DMC plans • Collaborate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, and other partners • Write, test, and validate SAS programs producing analysis datasets, tables, listings, graphs, and presentation outputs • Execute and develop department-, product-, and study-level macros and utilities • Provide technical guidance on complex programming tasks and standards • Contribute to Statistical Programming policies, standard operating procedures, and controlled documents • Interface with outsourcing partners and vendors

🎯 Requirements

• Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject, or equivalent related experience • Minimum 5+ years of clinical research and development programming experience using SAS • Expert-level SAS programming experience delivering complex programming assignments and analyses • Knowledge of SDTM and ADaM standards • Experience writing CDISC-standard dataset specifications • Experience creating SDTM and ADaM datasets from specifications • Ability to develop, test, and validate analysis datasets, tables, listings, graphs, macros, utilities, and presentation outputs • Expert-level knowledge and extensive hands-on experience with CDISC methodologies • Experience leading or working with centralized Statistical Programming teams • Experience in oncology trials • Experience with FDA, EMEA, and CFDA clinical trial and regulatory submissions • Experience with the drug development process in preclinical, early, late-stage, and/or observational settings • Knowledge of drug development fundamentals and project planning and management • Excellent verbal and written communication skills • Ability to collaborate effectively in a dynamic environment

🏖️ Benefits

• Annual bonus plan eligibility for Non-Commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness