Manager Biostatistics

Title: Manager, Biostatistics

Location: Bothell, WA

Duration: 12+ Months

The incumbent is the statistical lead for multiple clinical trials. This role will work closely with cross-functional teams to ensure appropriate study design, statistical analysis and reporting, and study result interpretation of clinical trials in achieving regulatory, scientific, and business objectives.

KEY ROLE AND RESPONSIBILITIES:

• Work collaboratively with clinical science, statistical programming, clinical data management, clinical operation, drug safety, translational research, regulatory and project management to meet project deliverables and timelines for statistical data analysis and reporting
• Author statistical sections in protocols, including sample size calculation
• Author Statistical Analysis Plans, mockups, and specification of TLFs for clinical trials
• Apply advanced statistical methodologies to study design and clinical development plan
• Manage vendors and oversee statistical deliverables to ensure the quality of deliverables and ensure the timelines are met
• Perform biomarker and exploratory analyses using advanced statistical methods
• Develop and maintain SAS macros, TLF templates and programming standard
• Review and support the development of CRF design
• Participate, review, and provide statistical input on study documents, such as protocol, IB, DSUR, CSR, etc.
• Experience in biotechnology or pharmaceutical industry
• Vendor oversight experience
• Demonstrated knowledge and programming skills in SAS and/or R
• Proven experience in oncology (hematology-oncology or solid tumors)
• Exposure to, and experience in machine learning

KNOWLEDGE, SKILLS AND ABILITIES:

• Solid understanding of overall drug development process and clinical trials
• Strong knowledge and understanding of ICH guidance and GCP standard
• Excellent verbal and written communication skills with the ability to facilitate conversations across teams
• Proven ability to work well in a matrix team environment

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