Seagen

Senior Principal Statistical Programmer

Development - Bothell, Washington

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

Lead large statistical programming teams working on the full portfolio of Phase I-IV clinical studies across multiple products. Ensure project and analysis level deliverables are completed on time, in high quality, and in accordance with company, industry, and regulatory requirements. Proactively drive and contribute to departmental strategies for continuous improvement of efficiency and quality through innovation and standardization. Develop high-performing staff members. Prepare resource plans to support budgets and manage resource allocation across studies and projects.

Principal Responsibilities:

• Define and implement statistical programming strategies to support timely and high-quality reporting and submission of data on clinical studies across multiple products
• Decide on implementation of departmental, regulatory, and industry standards at the product level, and advise leads on such implementation at study, project, or filing level, for all assigned products
• Decide on allocation of internal and external statistical programming resources to studies and projects within the assigned portfolio. Advise functional leadership on future resource needs or availability for the assigned portfolio and for departmental assumptions underpinning functional resource projections
• Ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables supporting clinical trial analysis, reporting, and regulatory review. Varying degrees of hands-on contribution to programming (production or QC) along with personal review of data sets, output, and metadata is expected especially on pivotal trials and on integrations
• Represent Statistical Programming in close collaborations with Biostatistics, Development Operations, Project Management, Data Management, Drug Safety, Regulatory, and others to achieve cross-functional alignment for assigned products. Decide on programming-related cross-functional matters at the product level and advise lead programmers on such matters at study or project level
• Provide technical leadership to team members proactively and on demand, including programming techniques and implementation of standards
• Proactively advise on continuous improvements to owners of departmental processes, standards, and utilities. As a lead on departmental initiatives that facilitate standards, infrastructure, and process enhancements across Biometrics, decide on their designs and implementation, and provide advice as a contributor on other such efforts
• Provide oversight, guidance, mentoring, goal setting, feedback, and performance reviews to direct reports. Structure development planning for direct reports to effectively grow their career in alignment with business goals, and position reports who themselves are managers to enable their staff in the same manner
• Recruit high-performing staff and train and mentor new and junior programmers

Qualifications:

• 14+ years (BS) or 12+ (MS/PhD) of statistical programming experience in the Biotechnology, Pharmaceutical, Medical Device, CRO, or Healthcare industries
• 6+ years of direct line management of salaried staff
• Expert knowledge and understanding of SAS® programming concepts and skills
• Demonstrated proactivity and strong attention to detail
• Excellent understanding of and hands-on experience with CDISC SDTM and ADaM standards
• Experience in Oncology studies; experience with integrations (ISE/ISS) and regulatory submissions

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, 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.

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: 04/01/2022