Summary / Purpose:
Provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans (SAP), developing SAS programs, and interacting with clients, and participate in FDA meetings as needed.
Key Accountabilities / Core Job Responsibilities:
• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Provides statistical consultation on trial design and study endpoints, calculates sample sizes and authors statistical analysis plans, utilizes knowledge of Regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program, and uses knowledge of literature to provide data analysis and presentation methods to support publications/presentations. Works on 4-6 clinical trials / projects as well as other tasks as assigned by supervisor.
• Works on 4-6 clinical trials / projects as well as other tasks as assigned by supervisor.
• Leads a specific component of a departmental strategic initiative.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Must have scientific programming capability with statistical software packages.
• Analyzes and utilizes complex information.
• Anticipates change and reacts quickly and proactively to accommodate business need.
• Proactively solicits views from others to gain common understanding and agreement.
• Leads by example and resolves conflict; manages processes for maintaining team cohesiveness.
• Uses statistical expertise to demonstrate effective persuasion.
• Understands strategic value of information and knows when and when not to communicate.
• Works independently on their own projects or studies.
• Leads the statistical analysis of a project or study in conjunction with Data Management and Statistical Programming.
• Constantly interacts with team members to challenge and generate new ideas.
• Understand the operations of the Biometrics function with clear expectation of the responsibility from other functional groups.
• Work supports multiple projects simultaneously.
• High degree of competence in experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming.
• Oncology trial experience is preferred.
• Strong interpersonal and effective written and verbal communication skill.
Education and Experience:
• 6+ years of industry experience in the statistical analysis of biomedical data using SAS® software and a BS degree in Biostatistics or equivalent.
• 2+ years of industry experience in the statistical analysis of biomedical data with an MS degree in Biostatistics or equivalent.
• 1+ years of industry experience in the statistical analysis of biomedical data with an PhD degree in Biostatistics or equivalent.
How to Apply:
Send cover letter with your resume to email@example.com.