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Seagen Inc Principal Biostatistician in Bothell, Washington

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Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagens dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Job Summary:

Provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards.

Detailed Duties & Responsibilities Typically Include:

Provide leadership to the biometrics team on one or more clinical programs or key studies; review work of statisticians supporting this work

Provide update to management on program progress with focus on biometrics

Collaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designs

Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a design

Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements

Design and write statistical sections for clinical trial protocols or oversee this work

Generate study randomizations and provide inputs on maintaining study blinding

Develop statistical analysis plans for clinical trials or oversee this work

Write statistical sections of regulatory submissions or oversee this work

Design and conduct statistical analysis of clinical data or oversee this work

Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff

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