Manager/Sr. Manager, Statistical Programming

Seattle Genetics Bothell , WA 98021

Posted 2 months ago

Summary:

Oversight and management of statistical programming activities for Phase I-IV clinical studies. The primary focus is to ensure that product and study level deliverables are completed on time, of high quality, and in accordance with company, industry, and regulatory requirements. In addition, this position will lead and manage both salaried and contract programmers.

Responsibilities:

  • Responsible for the accuracy, completeness, quality, and timely delivery of clinical programming deliverables at the product and study level

  • Ensuring programming is conducted according to departmental and industry standards

  • Recruiting and retaining high performing programmers

  • Managing salaried and contract programmers efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback, and performance reviews

  • Contributing to the development of departmental utilities, processes, and procedures

  • Interpret study documentation and industry guidance to produce programming requirements and specifications

  • Provide SAS programming support for a variety of activities including but not limited to creating outputs for: integrated analyses, clinical study reports, safety monitoring, manuscripts, conferences, ad hoc analyses, and exploratory analyses. Attend cross-functional clinical study team meetings and lead study / product programming meetings as appropriate

  • Review and provide feedback on deliverables from other clinical groups including: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; electronic data entry screens; and case report forms

  • Overseeing outsourced studies and vendors as appropriate

Qualifications:

  • BS or equivalent relevant education and 8+ years or MS/PhD and 6+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education

  • Advanced SAS skills

  • 5+ Years of experience in clinical programming project management

  • Expert at implementing CDISC standards

  • Experience with regulatory submissions (e.g. BLA, NDA, NDS, MAA, etc.)

  • Positive, professional attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area

  • Excellent written and verbal communication skills

Education:

  • Manager: BS or equivalent relevant education and 8+ years or MS/PhD and 6+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education

  • Sr. Manager: BS or equivalent relevant education and 10+ years or MS/PhD and 8+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education

  • Degree in Biostatistics, Statistics, Math preferred

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/Sr. Manager, Statistical Programming

Seattle Genetics