Designs, develops, and modifies SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. Recognizes inconsistencies and initiates resolution of data problems. Provides subject matter expertise in review of key study and project documents and analysis or data set specifications. Acts as a liaison between clinical, drug safety, and study programming teams as needed. Writes, tests, and assists with the standardization of programs and utilities up to the departmental level. Writes requirements and specifications with consideration of cross-protocol consistency, participates in the creation of study- or project-level documentation, and assists with the setup of new studies and/or analyses. Ensures adherence to regulatory and company standards at the protocol level. Provides support for ongoing regulatory and safety reporting needs for regulatory submissions and internal decision-making.
- Independently develop and validate SAS® programs to produce high-quality datasets, tables, listings, and figures within set timelines in accordance with company and regulatory requirements
- Independently implement routine and non-standard analysis algorithms for assigned projects or studies
- Provide statistical programming support for one or more studies or projects
- Under supervision of a Manager or above, may function as the lead programmer on a study or other end-to-end programming project
- Ensure compliance with company and industry standards
- Contribute to data set or TFL specifications for assigned projects or studies, or decide on project- or study-level implementation if functioning as lead programmer, under supervision of a Manager or above
- 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
- Clear and proactive communication with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities.
- Participate in or lead initiatives that facilitate standards, infrastructure, and process enhancements across Biometrics
- Train and mentor new and junior programmers
- 7+ years (BS) or 5+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, and Healthcare 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 writing SAS macros
- Advanced SAS® skills
- Demonstrated proactivity and strong attention to detail
- Good understanding of and hands-on experience with CDISC SDTM and ADaM standards
- BS, MS, or PhD
As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.
Seagen 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.