Senior Manager, Scientific ProgrammingBeiGene, Ltd. • New York, New York, United States
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Senior Manager, Scientific Programming
BeiGene, Ltd.
- New York, New York, United States
- New York, New York, United States
Über
BeOne is recruiting a Senior Manager, Statistical Programming Project Lead to lead project development, oversee programming deliverables across multiple indication development programs. Responsibilities
Collaborate with lead project Biostatistician in strategic planning and provide guidance to the programming team. Create, implement, and maintain programming development plans for each project, accounting for timelines, resources, and quality deliverables. Ensure programming meets industry and internal standard practice. Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines. Contribute to development and implementation of programming resource algorithms. Collaborate with programming managers and project leads, lead resource planning and tracking. Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, and Medical Writing to address programming related study deliverables. Contribute to strategies for programming related matters in submissions to regulatory agencies and publications. Understand and execute department, product, and study-level macros and utilities; write, test, and validate them. Serve as a technical resource for programming groups on complex tasks and standards. Assist in review of key study-related documents (e.g., SAP, CRF, data management plan, database specs, eDC structures, DMC plans). Oversee projects for creation of analysis datasets, production/validation of output, and review of annotated CRFs. Provide statistical programming support for FDA/EMEA/CDE regulatory submissions following CDISC standards. Contribute to departmental process and standards initiatives such as tools and CDISC standards. Collaborate and support selection and management of CROs, including strategic outsourcing providers. Oversee work in support of clinical trials, ad‑hoc analysis requests, data validation, etc. Lead development of TAUG (therapeutic area user guide) following CDISC industry standards. Other duties as assigned. Qualifications
Master's degree in a quantitative or scientific field (e.g., Computer Science, Statistics, Mathematics, Life Science) preferred. 5+ years of relevant experience in statistical programming. Experience with CDISC standards (SDTM, ADaM). Familiarity with regulatory submission deliverables (e.g., TFLs, ISS/ISE, eCTD). Knowledge of clinical data structures and study designs. Experience with ClinPharm/PK analyses. Familiarity with workflow automation and reproducibility. Ability to oversee multiple studies or programs. Vendor/CRO oversight experience. Cross‑functional collaboration with Statistics, Clinical, Data Management, Clinical Pharmacology, Medical Writing, and Regulatory. Proficiency in SAS (Base, Macro, SQL), R, Python, SQL. Compensation
Salary range: $144,400.00 – $189,400.00 annually. Equal Opportunity Statement
BeOne is a proud equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
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Sprachkenntnisse
- English
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