Our biotechnology client, who has experienced tremendous success with their oncology drugs in clinical trials has a full-time, direct hire opportunity for a Senior Manager of Statistical Programming in their San Francisco Office (position can also reside out of their Los Angeles office).
You will work with collaboratively with Biostatisticians, Statistical Programmers, 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. You will participate in reviewing vendor audit plan and statistical analysis plan as needed; participate in vendor qualification and selection and participate in monitoring vendor performance. This position reports to the Senior Director, Data Management and Programming.
Skills & Qualifications:
• Bachelor’s Degree in a Computer Science, Mathematics, Statistics or a quantitative/ analytical field
• Minimum of 8 years of clinical trial programming experience in the biotechnology/pharmaceutical/ contract research industry
• Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
• Basic knowledge of coding dictionaries – MeDDRA and WHODRUG
• Supervisory experience
• Vendor management experience
• Excellent organizational skills and ability to prioritize tasks
• Must be able to work under tight timelines
• Possess excellent communication and interpersonal skills
• Demonstrate good negotiation skills
• Takes initiative