Principal/Sr. Principal Biostatistician
Provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards.
- Provide leadership to the biometrics team on one or more clinical 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 a design
- Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements
- Design and write statistical sections for clinical trial protocols or oversee this work
- Generate study randomizations and provide inputs on maintaining study blinding
- Develop 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 ensure analyses are performed appropriately by programming staff
- Represent Seattle Genetics statistical position to regulatory agencies
- Key contributor in project planning
- 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
- Principal: MS with 6+ years or PhD with 4+ years of experience as a study statistician with high independency for complicated studies
- Sr. Principal: MS with 8+ years or PhD with 6+ years of experience as a program lead statistician for early phase programs or pivotal studies in late-stage drug development
- Previous experience providing leadership to biometrics staff within a clinical team
- Knowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians.
- Excellent communication and presentation skills, both written and verbal
- Knowledge of FDA regulations, ICH guidelines, the drug development process
- Proficiency with SAS® procedures and programming language
- Submission experience a plus
- Strong simulations experience/skills
- Oncology experience preferred
- Proficiency with S-Plus or R a benefit
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.