Manager / Sr. Manager, Statistical Programming Job in Bothell 98021, Washington Us

Seattle Genetics is seeking a SAS programming manager to oversee statistical programming activities for Phase I-IV clinical studies with a focus on supporting late stage 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. The secondary focus is to manage salaried and contract programmers.

 

Functional Role:

The position reports to the Head of Statistical Programming and will function as a Manager, Study Lead Programmer, and Support Programmer.

 

Responsibilities:

·         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.

·         Managing salaried and contract programmers efficiently across studies.

·         Contributing to the development of departmental utilities, processes, and procedures.

·         Developing programming support for Medical Affairs and late stage studies.

 

Activities:

·         Manage other salaried and contract programmers of varying levels to provide oversight, guidance, mentoring, feedback, and performance reviews.

·         Attend cross-functional clinical study team meetings and lead study programming meetings.

·         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.

·         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.

·         Set up and maintain programming infrastructure at the product and study level.

·         Assist with the development, maintenance, and presentation of standard macros, utilities, processes, procedures, guidelines, and training materials to support a variety of activities in the Clinical Programming group.

 

Requirements:

·         Ten years of SAS programming experience on Phase I-IV clinical studies in the Biotech, Pharmaceutical, and/or Medical Device industry.

·         Demonstrated programming project management experience including a minimum of two years of experience managing direct reports.

·         BS/BA in Computer Science, Statistics, Life Sciences or related discipline. MS preferred; years of experience may substitute for advanced degree.

·         Good written and verbal communication skills.

·         Demonstrated ability to manage clinical programming projects.

·         In depth familiarity with CDISC V3.x preferred.

·         Strong work-ethic and positive attitude.

 

Seattle Genetics is an equal opportunity employer

 

To apply for this position, please click on the following link:  https://tbe.taleo.net/NA9/ats/careers/requisition.jsp?org=SEAGENcws=1rid=964