Manager Statistical Programming

Seattle Genetics South San Francisco , CA 94080

Posted 3 months ago

Summary:

Seattle Genetics is seeking a Manager, Statistical Programming 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 environment, all while maintaining adaptability and high decision quality and creating the same environment for your direct reports.

In this role, you will oversee statistical programming activities for Phase I-IV clinical studies. You will ensure that product and study-level deliverables are completed on time, in high quality, and in accordance with company, industry, and regulatory requirements. You will manage salaried, contract, and remote FSP programmers and be expected to manage not only work performance but also professional development and growth opportunities for your direct reports.

Responsibilities:

  • Ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables at the study, filing, or small product level

  • Independently implement complex analysis algorithms for assigned projects or studies

  • Provide technical leadership to study team programmers including programming techniques. Decide on extent of implementation of departmental and product-level standards, tools, and processes in assigned studies with advice from the product lead programmer

  • Contribute to product-level specifications 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

  • 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 assigned projects to maximize synergies

  • Provide oversight, guidance, mentoring, feedback, and performance reviews to direct reports

  • Participate in interviews and, as a hiring manager, decide with candidates to hire. Train and mentor new and junior programmers

  • Assist programming management on resource allocation

Qualifications:

  • 8+ years (BS) or 6+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, and Health Care 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 trials

  • 3+ years of experience in managing statistical programming projects, preferentially (but not necessarily) with direct line management responsibilities for internal salaried staff

  • 2+ years of experience in writing SAS macros

  • Demonstrated proactivity and strong attention to detail

  • Expert knowledge and understanding of SAS programming concepts and skills.

  • Experience in oncology studies; experience with integrations and e-submissions a strong plus

  • 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, 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.

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Manager Statistical Programming

Seattle Genetics