Seattle Genetics is seeking a Senior level SAS programmer to support clinical programming activities for multiple Phase I-III clinical oncology studies, primarily focusing on the reporting of safety data. This role interacts at varying degrees with representatives from Clinical Data Management, Biostatistics, Medical Writing, Safety, and Clinical Information Systems to write requirements, specifications, and timelines and support the programming team to ensure high quality programming deliverables are provided in accordance with company, industry, and regulatory requirements.
Accuracy, completeness, quality, and timeliness of Clinical Programming deliverables at the product and study level.
Clear and proactive communication within the Clinical Programming group and with representatives from other functional groups to convey resource needs, assignments, deliverables, timelines, requirements, specifications, processes and procedures.
Translating general high-level project requests into detailed tasks, and ensuring the completion of those tasks.
May oversee certain aspects of the safety programming activities for multiple clinical studies.
Programming infrastructure at the product and study level.
Maintaining and enhancing a positive reputation for the Clinical Programming group within the company and the industry.
Translating company and Clinical Programming goals into product and study specific goals and ensuring their completion
Participating with and in cases leading process and technical improvement initiatives.
Provide programming support for a variety of clinical development activities including but not limited to creating outputs for: regulatory reporting; risk management; interim analyses; signal detection; safety updates; manuscripts; conferences; ad hoc analyses; and exploratory analyses.
Review and provide feedback on deliverables from other clinical and safety groups including but not limited to: statistical analysis plans; specification documents, table, listing, and figure shells; data management plans; data transfer plans; electronic data entry screens; and case report forms.
Assist with the set up and maintenance of programming infrastructure at the product and study level.
Write and test primarily SAS programs that create macros, catalogs, analysis datasets, tables, listings and figures.
Review deliverables from other programmers and ensure they are complete, accurate, and consistent with internal and external requirements and standards.
Assist with the development, maintenance, and presentation of standardmacros, utilities, processes, procedures, guidelines, and training materials to support a variety of activities in the Programming group.
Attend industry conferences as a representative of the Seattle Genetics Clinical Programming group
Five to ten years of software development and/or Programming experience in the Biotech, Pharmaceutical, and/or Medical Device industry. Three to five years of which must be Programming in SAS on Phase I-IV clinical studies.
BS/BA in Computer Science, Engineering, Statistics, Life Sciences or related discipline. Years of experience may substitute for advanced degree.
Experience supporting Drug Safety Operations with Signal Detection, Risk Management, and Periodic Safety Updates programming activities is a plus.
Strong Experience with additional programming languages and tools such as Perl, VBA, MS Excel, and SQL that interface with SAS is a plus.
Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
Strong business acumen with a good understanding of the multi-disciplinary functions involved in a companys drug development process.
Good written and verbal communication skills.
|Seattle Genetics, Inc.|
State or Province