Provide statistical expertise on clinical development, ranging from proof-of-concept trials to regulatory filings and post-market studies. Manages biostatisticians (both fulltime and contractor) and oversees their work based on level of experience. Provides coaching and mentoring on an individualized basis for career development of their direct reports. Lead a project team or a significant component of a project. Collaborate with clinical colleagues in developing innovative clinical trial designs. Apply scientific rigor to analysis methods and data interpretation. Provide statistical leadership in product development plans to support regulatory strategies. Represent company in meetings with regulators, external experts, and partners. Ensures adherence to regulatory and company standards.
- Hire and retain talent
- Provide career growth opportunities for staff
- Define resource needs and determine use of in-house, contractors, or CRO
- Provide leadership to the biometrics team on multiple 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 designs
- Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements
- Write statistical sections of regulatory submissions or oversee this work
- Develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
- Represent Seattle Genetics statistical position to regulatory agencies
- Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
- Support, and identify need for, the development and improvement of department tools, templates, guidelines, SOPs, and systems.
- Strong knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- MS in statistics, biostatistics, or related field with 10+ years of experience, or PhD with 8+ years of experience
- Oncology experience
- Knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
- Previous experience providing leadership to biometrics staff within a clinical team
- Excellent communication and presentation skills, both written and verbal
- Sound understanding of ICH guidelines and FDA requirements
- Proficiency with SAS® procedures and programming language
- Ability to work independently
- Good analytical skills
- Good project management skills
- Professional attitude
- Ability to direct and promote teamwork in a multi-disciplinary team setting
- Ability to work with others
- Address technical issues effectively with written and verbal communication
- Explain statistical issues effectively to technical and non-technical staff
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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.