Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

Job Description: Senior Level Statistician will provide statistical expertise in support of clinical development.

• Key contributor to study design and analysis of clinical data related to company’s development programs.
• Efficiently and effectively coordinate statistical activities for multiple studies, including development of protocols and statistical analysis plans and presentation of results in clinical study reports and other relevant documents.
• Support planning and execution of integrated analyses for regulatory submissions. 
• Oversee the work of CROs that are performing statistical activities.

Qualifications:

• MS or Ph.D. in Statistics, Biostatistics or equivalent required.
• Minimum 7-10+ years of Biostatistics experience in drug-development and clinical research.
• Seeking a strong independent Biostatistician
• Proficient in R Programming
• Experience partnering with CROs to manage timelines and deliverables.
• Experience in study design, sample size calculations, and simulations
• Early phase experience is preferred (phases I and II)
• Looking for candidates who have worked in a variety of therapeutic areas
• Must be able to explain statistical techniques and considerations to non-statisticians.
• Excellent communication skills are a must
• High attention to detail including ability to manage competing priorities.
• Working knowledge of relevant FDA, EMA and ICH guidelines and regulations. 
• Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.