Lead Clinical Statistician

Clinical Statistician to participate in cross functional drug development teams,
liaise with CRO trial statisticians and data managers, develop Statistical Analysis Plans with
contractors, prepare the statistical section of clinical protocols, assist with the design of Clinical
Report Forms and contribute to Clinical Study Reports. Successful candidates will primarily be
responsible for statistical operations, analysis of clinical studies, data presentation, report writing,
providing statistical representation to the FDA, as well as statistical consulting support in pre-clinical
discovery work.
REQUIREMENTS
Required/Mandatory Skills
Successful candidates will have a Ph.D. in Statistics with 5 or more years of clinical research
experience and familiarity with preparing data for FDA/CDER submission. Additional formal training
in pharmacology or chemistry is preferred. Experience liaising with the FDA/CDER, as well as SAS
programming and excellent practical, organizational, interpersonal, oral and written communication
skills are a must.