Senior Biostatistician

The Senior Biostatistician provides, and may lead, statistical contributions to a clinical development program. The Principal Biostatistician implements statistical strategies for clinical trials and regulatory submissions within the program and is accountable for all statistical deliverables. Main Responsibilities and Accountabilities Contribute to the statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions. Provide statistical support for data collection, analysis, reporting, and submission preparation. Ensure the timely completion and quality of the Statistical Analysis Plan (SAP). Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA). Interpret analysis results and ensure accuracy and clarity of reporting. Manage outsourced statistical activities or collaborate with internal statistical programmers; ensure the timeliness and quality of CRO/FSP deliverables and conduct quality reviews. Oversee preparation of Tables, Figures, and Listings (TFLs) and CDISC packages for study reports and regulatory submissions. Support continuous improvement initiatives and contribute to standards related to infrastructure, processes, and scientific consulting. Job Qualifications and Experience Requirements Education PhD or MS in Biostatistics, Statistics, or a related field Experience PhD with at least 3 years of experience in drug development, or MS with at least 6 years of experience in drug development Advanced knowledge of statistical methodologies in clinical development Ability to collaborate effectively and provide leadership in a matrix environment Strong interpersonal and communication skills (written and verbal in English) Proficiency in SAS and/or R Familiarity with relevant regulatory guidance documents Technical Expertise CDISC standards, statistical programming, and/or data standards Biostatistics and Statistical Programming Operations

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