Vice President Head of Late Stage Biostatistics

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: 

Reporting to the SVP of Biometrics. Responsible for providing strategic input as it relates to program decisions and will contribute to the success of the Clinical Development team. This individual will provide strategic direction and oversee Biostatistics efforts on Late-Stage Drug Development and Health Technical Assessment. To optimize quality and efficiency of biostatistics deliverables, this individual develops and executes a strategic vision to ensure systems, capabilities and resources are in place to optimize the design, conduct, analysis, and interpretation of clinical data for each program. Ensure credible communication of clinical trial data internally and to Health Authorities, the academic community, and healthcare providers, as appropriate. Ensure that the interpretation of data obtained from our trials, from trials conducted by our collaboration partners, CROs and competitive data is accurate, scientifically sound and credible. In addition, this individual will be accountable for planning and oversight of the budget, building a world class biostatistics team, identifying technology needs, and scaling the organization to support global multi-products drug development and reimbursement. Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee development and retention activities. Gaining cross-functional cooperation, managing timelines, creating and delivering presentations of technical information, communicating effectively, and solving problems are keys to success. This individual will be collaborating with external corporate development partners where applicable.   

Principal Responsibilities: 

  • Provide strategic and technical oversight on drug development, including study design, conduct, and analysis, regulatory filings, drug reimbursement, and post-market studies 
  • Build and develop a high performing biostatistics team 
  • Provide strategic insight by keeping abreast of emerging statistical methodology, in drug development and drug reimbursement and providing long range plans to execute on those insights for the organization 
  • Develop and promote a workplace culture that values diversity of thought and promote integrity to create an atmosphere that supports coaching and fosters accountability 
  • Support preparations for interactions with regulatory agencies and drug reimbursement governance. Provide strategic guidance to ensure high quality preparation of all the relevant documents and interactions  
  • Serve as Expert to represent company in meetings with regulators, external experts, and partners whenever needed 
  • For the late-stage drug development programs and Health Technology Assessment Biostatistics efforts, provide leadership and oversight for all aspects of the efforts, facilitate knowledge sharing and creation, and improve overall quality and processes 
  • Develop strong and collaborative working relationships with key business stakeholders 
  • Define resource needs and determine use of in-house, contractors, or CRO 
  • Support and identify needs for the development and improvement of department tools, templates, guidelines, SOPs, and systems. Ensure adherence to the regulatory and industry standards and the relevant company SOPs 

Required Qualifications: 

  • PhD in statistics or biostatistics with minimum of 14+ years of relevant experience in the pharmaceutical or biotechnology industry, including 8+ years of people management experience 
  • Oncology experience is required, and broad drug development experience is highly preferred  
  • Extensive knowledge of clinical trial development, statistical methodology related to trial. design and conduct of clinical studies, as well as drug reimbursement experience is required 
  • Demonstrated strong abilities in statistical research and application of innovative methods to clinical trial development. Strong simulation experience and skills are highly preferred 
  • Extensive experience with global regulatory filings and approvals as well as health technical assessment 
  • Comprehensive understanding of ICH, GCP, global regulatory requirements, as well as drug reimbursement guidelines 
  • Leadership experience with proven capability as a successful leader in a multifunctional environment 
  • Strong mentoring abilities to build and develop biostatistics talents. Extensive experience working with statistical programming group. Ability to direct and promote teamwork in a multi-disciplinary team setting and work collaboratively with other groups 
  • Strong oral and written communication skills 

 

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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