Principal Statistical Programmer FSP

The Principal Statistical Programmer will work fully embedded within a pharmaceutical client, supporting the client's innovation and driving the next generation of patient treatment. This role involves generating SDTM, ADaM specifications, datasets, and other reporting and analysis activities for clinical trials.

Requirements

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables and complex graphs
• Deliver high-quality statistical programming results
• Participate in overseeing CRO’s statistical programming deliverables
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance