Seattle Genetics, Inc. Senior Statistical Programmer I/II in Bothell, Washington
Senior Statistical Programmer I/II
Designs, develops, evaluates and modifies SAS programs to analyze and evaluate clinical data. Recognizes inconsistencies and initiates resolution of data problems. Implements statistical analysis plans designed to meet project and protocol deadlines; provides expertise in the design and development of clinical trials, protocols and case report forms. Acts as a liaison between clinical management, subcommittees and project teams as needed. Interacts with study teams at a high level to proactively determine programming tasks, timelines, assignments, and resource requirements. Oversees study programming effort to ensure the timely delivery of high quality outputs that are produced according to company and industry standards. Assists programming management with process improvement initiatives and resource allocation.
Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures
Review and provide feedback on deliverables from other clinical groups including but not limited to: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms
Clear and proactive communication with Study / Project teams to clarify requirements and specifications, update others on assignment status, and to convey data irregularities
Oversee study programming effort to ensure the timely delivery of high quality outputs that are produced according to company and industry standards
Provide support on initiatives that facilitate infrastructure & process enhancements within Biometrics
Train and mentor junior programmers.
BS or equivalent relevant education and 7+ years or MS/PhD and 5+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education
Advanced SAS® skills
3+ years of experience in performing statistical programming using SAS® for creating & testing Analysis Datasets, Tables, Listings and Figures for Phase I-IV clinical studies
2+ years of experience in writing SAS® Macros
Experience with oncology clinical studies
Experience implementing CDISC standards
Experience with regulatory submissions (e.g. BLA, NDA, NDS, MAA, etc.)
Experience with additional programming languages and tools such as S-Plus, R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS
Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area
Good written and verbal communication skills
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.