Sr. Statistical Programmer in Bothell, WA

$150K - $200K(Ladders Estimates)

Seattle Genetics   •  

Bothell, WA 98011

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 93 days ago

This job is no longer available.

n this role, you will design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans. You will contribute expertise in the review of case report forms, data management plans, and data set or reporting specifications. You'll liaise between clinical and study programming teams as needed. You will write, test, and assist with the standardization of programs and utilities up to the department level. You will write requirements and specifications with consideration of regulatory and company standards as well as cross-protocol consistency, participate in the creation of study-level documentation, and assist with the setup of new studies. You may also provide support for ongoing regulatory and safety reporting needs for regulatory submissions.

Responsibilities:

  • Develop and validate SAS® programs to produce high-quality datasets, tables, listings and figures within set timelines in accordance with company and regulatory requirements
  • Independently implement routine and non-standard analysis algorithms for assigned projects or studies
  • Provide statistical programming support for one or more studies
  • Ensure compliance with company and industry standards; contribute to defining specifications for assigned studies when appropriate
  • 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
  • Communicate clearly and proactively with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities
  • Participate in initiatives that facilitate infrastructure and process enhancements within Biometrics
  • Train and mentor junior programmers

Requirements:

  • BS and 7+ years of software development and/or programming experience in the biotech, pharmaceutical, medical device, or healthcare industries; or MS/PhD and 5+ years of software development and/or programming experience in these 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 writing SAS macros
  • Advanced SAS® skills
  • Demonstrated proactivity and strong attention to detail
  • Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards


Valid Through: 2019-8-15