Description
We are seeking a Principal Statistician Oncology with Submission Experience to join our Clinical Solutions team. As a Principal Statistician, you will serve as a statistical department resource, mentor biostatisticians, and oversee or develop training plans or materials for Biostatistics associates.
Responsibilities:
- Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work
- Provides independent review of project work produced by other biostatisticians in the department
- Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures
- Collaborates with sponsor, if required
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
- Reviews SAS/R annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met
- Implements company objectives and creates alternative solutions to address business and operational challenges
- Interfaces with other departmental project team representatives as biostatistics representative on project teams
- Conducts and participates in verification and quality control of project deliverables
- May lead complex or multiple projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and proactively communicates to biostatistics management any difficulties with meeting these timelines
- Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met
- Provides statistical programming support as needed
- Participates in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician
- Maintains well-organized, complete, and up-to-date project documentation and verification/quality control documents and programs
- Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business
- Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings
Qualification Requirements:
- Graduate degree in biostatistics or related discipline
- Extensive experience in clinical trials or an equivalent combination of education and experience
- Proficiency in programming
- Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English
Benefits:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture