Seagen

Senior Director Biostatistics (Methodology & Innovations)

Development - Bothell, Washington

Description

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 critical role will be focused on enhancing technical and strategic capabilities of Biostatistics at Seagen. The key responsibilities include, but are not limited to providing statistical expertise in all phases of clinical development to project teams in need; planning, driving and contributing to biostatistics methodology initiatives; conducting statistical research; collaborating with statisticians to assess and implement complex and innovative trail designs and analyses; providing training to statisticians and non-statistician colleagues; coaching and mentoring statisticians to help enhance their technical skills; and be part of the extended biometric leadership.

Principal Responsibilities:

• Lead, contribute and drive biostatistics methodological initiatives and promote best practices.
• Advise internal teams on methodological issues and help team resolve problems and make better decisions.
• Work with statisticians to assist with innovative trial design, simulation, and execution.
• Develop programming codes and tools to facilitate the implementation of complex methods.
• Conduct methodological research and present and/or publish research findings.
• Provides statistical training to statisticians and non-statistician colleagues.
• Keep abreast of new developments in statistics, drug development, and regulatory guidance.
• Support and identify the need for the development or improvement of department tools, templates, guidelines, SOPs, and systems.
• Recruit, supervise, develop, and retain talents if needed.
• Provide biostatistics support and leadership to specific clinical studies or programs when needed. This may include.
• Collaborating effectively with cross functional leaders to develop optimal clinical development plans.
• Providing statistically sound experimental design and analysis plans to meet project objectives and regulatory requirements.
• Authoring SAPs and DMC/SMC charters, contributing to study protocols, CSRs, regulatory submissions and responses or overseeing this work.
• Interpreting and presenting analysis results in a clear, concise, complete and transparent manner.

Qualifications:

• PhD in Biostatistics, Statistics or a related field.
• 12+ years of experience of clinical trials and methodological research in biopharma industry, regulatory agencies, or academia.
• Significant knowledge of innovative statistical designs and analysis methods for drug development.
• Proven excellence in statistical methodological research in clinical trials.
• Excellent verbal and written communication and presentation skills.
• Able to explain complex statistical concepts and thinking effectively to technical and non-technical staff.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Strong project management skills and expertise across large scale, complex projects.
• Prior experience of leading biostatistical support to clinical programs and/or statistical research, and team management experience.
• Experience of oncology drug development.
• Sound understanding of ICH guidelines and the requirements from global regulatory agencies.
• Proficiency in R/R-Shiny or SAS® programming.
• Consistent demonstration and embodiment of the company’s core values (passion for helping patients, scientific excellence, innovation, integrity, diversity, teamwork & mutual respect, and great work environment)

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.

The hiring pay range for this position is $283,000 to $366,300 per year based on skills, education and experience relevant to the role.   Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/13/2023