Seattle Genetics is seeking a Principal Statistical Programmer to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative and dynamic environment.
In this role, you will design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. In a leadership role on a study or integration, you will interact with cross functional study teams at a high level to proactively determine programming tasks, timelines, assignments, and resource requirements and oversee study or integration programming efforts to ensure the timely delivery of high-quality outputs according to company and industry standards. You will contribute expertise in the review of case report forms, data management plans, and data set or reporting specifications. As a detail-oriented team member, you will recognize inconsistencies and initiate resolution of data problems when necessary. You may also assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation.
* Develop and validate SAS® programs to produce high quality data sets, tables, figures, and listings within set timelines in accordance with company and regulatory requirements
* Independently implement complex analysis algorithms for assigned projects or studies
* Provide statistical programming support for several studies and integrations on a product
* Ensure compliance with company and industry standards, and contribute to specifications for assigned products based on analysis need and ensure compliance with company and industry standards
* 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, and case report forms
* Communicate clearly and proactively with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities
* Initiate, lead, and participate in planned departmental and cross functional initiatives that facilitate standards, infrastructure, and process enhancements
* Assist programming management on resource allocation
* Train and mentor new and junior programmers
* BS and 8+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, and healthcare industries; MS/PhD and 6+ years of software development and/or programming experience in these industries
* 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical studies
* 3+ years of experience in overseeing statistical programming projects
* 3+ years of experience in writing SAS macros
* Expert knowledge and understanding of SAS® programming concepts and skills
* Demonstrated proactivity and strong attention to detail
* Experience in oncology studies; experience with integrations and electronic submissions preferred
* Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards; understanding of electronic submission requirements and guidance preferred
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.