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Seagen Senior Principal Biostatistician in Bothell, Washington

Seagen Development ยท Bothell, WashingtonDescriptionPosition at SeagenSummary: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.Responsibilities: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 workProvide update on program progress with focus on biometrics to managementCollaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designsPerform or oversee performance of power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designsProvide statistically sound experimental design and data analysis input to meet project objectives and regulatory (e.g.FDA) requirementsDesign and write statistical sections for clinical trial protocols or oversee this workGenerate study randomizations and provide input on maintaining study blindingDesign and write statistical analysis plans for clinical trials or oversee this workWrite statistical sections of regulatory submissions or oversee this workDesign and conduct statistical analysis of clinical data or oversee this workWork with medical monitors to develop ad hoc analysis plans and perform analyses or ensure analyses are performed appropriately by programming staffRepresent Seattle Genetics statistical position to regulatory agenciesKey contributor in project planning (timelines, etc.) with clinical, regulatory and data managementKeep 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 systemsKnowledge of FDA regulations, ICH GCP guidelines, the drug development processQualifications:Principal: MS with 6+yrsor PhD with 4+yrs/study stat with high independency for complicated studiesPrincipal: MS with 8+yrsor PhD with 6+yrs/ Program Lead Stat for early programs or pivotal studies for late programsPrevious experience providing leadership to biometrics staff within a clinical teamKnowledge and experience to exercise independent judgment and provide indirect oversight to programmers, data managers, and more junior statisticiansExcellent communication and presentation skills, both written and verbalSound understanding of ICH guidelines and FDA requirementsProficiency with SAS procedures and programming languagePreferred Qualification