Principal Biostatistician

Development Bothell, United States


Description

Position at Seagen

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. Seagen’s 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! 

Summary:  

This position will provide leadership to the Biometrics team to support early phase development programs. Provides statistical/strategic inputs to the clinical development plans. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Performs or oversees the analysis of clinical trial data, provides statistical interpretation of results, and collaborates on the reporting of clinical trial results to regulatory authorities and scientific community. Ensures adherence to regulatory and company standards. Supports the departmental efforts in developing and implementing innovative statistical methods for clinical trials by conducting research and simulations. 

Responsibilities:  

  • Provides leadership to the Biometrics team on clinical studies for early development programs; reviews work of statisticians supporting this work 
  • Provides update to management on program progress with focus on biometrics 
  • Collaborates with medical monitors and other study personnel on the creation of clinical trial designs 
  • Performs or oversees power/sample size calculations to determine appropriate trial size; runs simulations to assess operating characteristics of a design 
  • Provides statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements 
  • Authors statistical sections for clinical trial protocols 
  • Authors statistical analysis plans for clinical trials 
  • Writes statistical sections of regulatory submissions 
  • Designs and conducts statistical analysis of clinical data 
  • Works with medical monitors to develop ad hoc analysis plans and ensures analyses are performed appropriately by statistical programmers 
  • Represents Seagen when interacting with regulatory agencies 
  • Key contributor in project planning 
  • Conducts statistical research and simulations to evaluate and implement innovative statistical methods 
  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings 
  • Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems 

Qualifications:  

  • PhD with 4+ years of clinical trial experience as a study statistician  
  • Solid statistical training and research background 
  • Proficiency in statistical programming languages such as R and SAS 
  • Experience of leading project or major studies 
  • Able to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians 
  • Excellent communication and presentation skills, both written and verbal 
  • Experience of oncology trials and endpoint assessments 
  • Knowledge of FDA regulations, ICH GCP guidelines, the drug development process 

 

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.  

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.  

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

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