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
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.
About Seattle Genetics
Seattle Genetics is dedicated to improving patient outcomes through advanced antibody-drug conjugate technology designed to deliver cell-killing agents directly to tumor cells.