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.

• 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.

• PhD or MS in Biostatistics, Statistics, or a related field

• 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

• CDISC standards, statistical programming, and/or data standards
• Biostatistics and Statistical Programming Operations