Sr. Manager, Statistical Programming

Seattle Genetics   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 60 days ago

This job is no longer available.

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 clinical programming deliverables at the product and study level
  • Ensure programming is conducted according to departmental, regulatory, and industry standards
  • Provide technical leadership to team members including programming techniques and implementation of standards
  • Set and implement cross-study standards for an entire product and ensure compliance with company and industry standards
  • Proactively recommend continuous improvements to departmental processes, standards, and utilities
  • 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
  • Actively lead and support departmental initiatives that facilitate standards, infrastructure, and process enhancements across Biometrics
  • Represent statistical programming function in collaborative cross-functional settings
  • Plan and manage resources efficiently across an assigned portfolio of studies and filings
  • Provide oversight, guidance, mentoring, goal setting, feedback, and performance reviews to direct reports
  • Recruit high-performing programmers and train and mentor junior programmers

Requirements:

  • BS and 10+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, or healthcare industries; or MS/PhD and 8+ years of software development and/or programming experience in these industries
  • 6+ 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
  • 5+ years of experience in managing statistical programming projects
  • 4+ years of experience in writing SAS macros
  • Previous people management experience
  • Expert knowledge and understanding of SAS® programming concepts and skills
  • Demonstrated proactivity and strong attention to detail
  • Experience in oncology studies; experience with integrations and electronic submissions preferred
  • Excellent understanding of CDISC SDTM and ADaM standards; understanding of electronic submission requirements and guidance preferred