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Job #02554

About our client Our client is a specialty pharmaceutical company. The company deals with diseases related to thickened or diseased skin and nails. The company uses a proprietary drug delivery technology, a first as well as the best in its class. Its approach to treatment is very innovative and patients with inflammatory and infectious diseases benefit from its local application therapies. The company generated late-stage clinical pipeline treats infectious/inflammatory diseases and satisfies unmet medical needs. Position Location Senior Biostatistician Seattle, Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide statistical support for ongoing clinical trials and regulatory interactions in the area of inflammatory and infectious disease 2) Collaborate with clinicians, data managers and other team members to design protocols and case report forms 3) Provide statistical support to multiple clinical trials, including the generation of the randomization codes, the statistical analysis plan, statistical tables, etc. 4) Collaborate with statistical programmers to develop and validate statistical programs for study reports and ad hoc analyses 5) Oversee the work of internal and external contractors and/or CROs performing assigned project work 6) Participate as a team member representing statistics in interactions with regulatory, investor and corporate partner discussions Requirements 1) Doctoral degree in Statistics or Bio-statistics (Ph. D. preferred) 2) Minimum 5 years of clinical trial experience 3) 3 years of experience in a pharmaceutical, biotech or a CRO setting 4) Experience in using SAS 5) Experience in dealing with CROs 6) Experience in dealing with the FDA 7) Knowledge of time-to-event and Mixed Effects Model (MEM) a plus 8) Excellent organizational and communication skills 9) Ability to work independently in a collaborative environment and a desire to improve skills 10) Willingness to work on-site 11) Willingness to travel (moderately)