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!
This position will report to Director, Biostatistics and provide leadership to the biometrics team (programming, data management, statistics) and statistical/strategic input into the clinical development plans while supporting all clinical trials within a program. The successful candidate will be a key contributor to clinical protocols for statistical concept as well as broader drug development concepts, perform or oversee performance of analyses of clinical trial data, provide statistical interpretation of results, and will collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community while ensuring adherence to regulatory and company standards.
- Provide leadership to the biometrics team (data management, programming, statistics) on a given clinical program, group of programs, or key study(ies); review work of statisticians supporting this work
- Provide update on program progress with focus on biometrics to management
- Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs
- Perform or oversee performance of power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designs
- Provide statistically sound experimental design and data analysis input to meet project objectives and regulatory (e.g. FDA) requirements
- Design and write statistical sections for clinical trial protocols or oversee this work
- Generate study randomizations and provide input on maintaining study blinding
- Design and write 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 perform analyses or ensure analyses are performed appropriately by programming staff
- Represent Seagen statistical position to regulatory agencies
- Key contributor in project planning (timelines, etc.) with clinical, regulatory and data management
- Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
- Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
- Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- MS with 8+ yrs or PhD with 6+ yrs/ Program Lead Stat for early programs or pivotal studies for late programs
- Previous experience providing leadership to biometrics staff within a clinical team
- Knowledge and experience to exercise independent judgment and provide indirect oversight to programmers, data managers, and more junior statisticians
- Excellent communication and presentation skills, both written and verbal
- Sound understanding of ICH guidelines and FDA requirements
- Proficiency with SAS® procedures and programming language
- Preferred Qualifications:
- Submission experience a plus
- Strong simulations experience/skills
- Oncology experience preferred
- Proficiency with S-Plus or R a benefit
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.