A well-established, secure and commercially active biopharma is expanding its US biostatistics team. This is a hands-on study statistician role within a fully in-house function.

Responsibilities

• Serve as study statistician across oncology trials
• Author and review Statistical Analysis Plans (SAPs) and statistical sections of clinical protocols
• Develop and review TFLs and outputs for regulatory submissions
• Conduct ad hoc statistical analysis and contribute to data review
• Support regulatory interactions, including IND, NDA/BLA submissions
• Collaborate cross-functionally with clinical development, data management, and programming

Experience Required

• PhD in Biostatistics or Statistics; Masters with supplementary experience considered
• Strong oncology experience
• Demonstrable experience working directly for a sponsor company
• Proficiency in SAS and/or R
• East Coast based only

Compensation

DOE - $160,000 - $200,000 base salary + benefits Remote Skills: Biostatistics, Clinical Data Management, Clinical Practices/Protocols, Cross-Functional, Drug Development, Oncology, R Programming Language, Regulations, Regulatory Submissions, Statistics, Writing Skills About the Company: Astera Search