Seagen

Principal Safety Statistical Programmer (Remote)

Development - Bothell, United States

Description

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!

Summary:

The Principal 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 with an emphasis on safety signal detection and risk evaluation in accordance with statistical analysis plans and other specifications provided by functional leads. In a leadership role on a study or similar project, like an integration, interact with cross-functional teams at a high level to proactively determine programming tasks, timelines, assignments, and resource requirements and oversee study, project, or integration programming efforts to ensure the timely delivery of high-quality output according to company and industry standards. Represent statistical programming in the review of key study and project documents and data set or reporting specifications. Recognize inconsistencies and initiate resolution of data problems when necessary. Assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation. May oversee activities performed by FSP or contract programmers.

Principal Responsibilities:

• Ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables at the study, project, filing, or early-stage product level
• Independently implement complex analysis algorithms for assigned projects or studies
• Provide technical leadership to study or project team programmers including efficient programming techniques. Decide on implementation of departmental and product-level standards, tools, and processes in assigned studies, projects, or integrations with advice from the lead programmer.
• Contribute to or take point on project- or product-level specifications based on analysis need and ensure compliance with company and industry standards
• 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
• Initiate, lead, and participate in planned departmental and cross-functional initiatives that facilitate standards, infrastructure, and process enhancements
• Manage resources efficiently across multiple projects to maximize synergies
• Assist programming management on resource allocation
• Interview, train, and mentor new and junior programmers
• Develop, maintain, and support project- or product-level utilities. Serve as an SME for technical questions from the team.

Qualifications:

• Proficient in key areas of responsibility; teaches others and functions independently; typically associated with an MS or PhD and 6+ years or a BS and 8+ years of experience in the Biotechnology, Pharmaceutical, Medical Device, and Healthcare industries using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical trials.
• Proficient SAS® programming skills
• 1+ years of experience in overseeing statistical programming projects, including project management (not necessarily line management) of staff working on those projects
• 2+ years of experience in writing SAS macros
• Good understanding of and hands-on experience with CDISC SDTM and ADaM standards
• Experience in oncology studies; experience with integrations and e-submissions a strong plus
• Experience in performing safety data integration and safety reporting to support signal detection and risk evaluation
• Deep understanding and experience in working with MedDRA and WHODrug coding dictionaries, as well as Standardized MedDRA Queries (SMQs)

Education:

• 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.

The hiring pay range for this position is $142,000 to $184,000 per year based on skills, education and experience relevant to the role.   Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/09/2022