Senior Statistical Programmer

Key Skills

Data management, Geospatial Statistical, SAS, Tableau

Job Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Position Summary:

The Sr. Statistical Programmer is an individual contributor with a strong focus on quality and results, who designs, develops, and modifies SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans and other specifications provided by functional leads. Function as the lead programmer on a study or similar project under light supervision. Recognizes inconsistencies and initiates resolution of data problems. Provides subject matter expertise in developing or reviewing 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 leads or assists with the setup of new studies and/or analyses. Ensures adherence to regulatory and company standards at the study level. Provides support for ongoing regulatory and safety reporting needs for regulatory submissions and internal decision-making.

Principal Responsibilities:

• Independently develop and test SAS® programs to produce high-quality data sets, tables, listings, and figures within set timelines in accordance with company and regulatory requirements
• Independently implement routine and non-standard analysis algorithms for assigned studies or projects
• Provide statistical programming support for one or more studies or projects
• Function as the lead programmer on a study or similar project under light supervision
• Make independent decisions at the task or study/project level
• Ensure compliance with company and industry standards
• Contribute to data set or TLF specifications for assigned projects or studies, or decide on project- or study-level implementation if functioning as lead programmer under light supervision
• Review and provide feedback on deliverables from other functional 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
• Interview, train, and mentor new and junior programmers

Qualifications:

• Competent in key areas of responsibility, uses knowledge to perform at a high level, typically associated with an MS/PhD and 5+ years or a BS and 7+ years of experience in the Biotechnology, Pharmaceutical, Medical Device, and Healthcare industries using SAS® for creating and testing analysis data sets, tables, listings, and figures for Phase I-IV clinical studies
• Advanced SAS® skills
• 2 years of experience in writing SAS macros preferred
• Good understanding of and hands-on experience with CDISC SDTM and ADaM standards

Education:

• BS, MS, or PhD