US - PA - Frazer


The Principal Statistician position is for a skilled scientist with training and experience in statistics, drug development, and clinical research. He or she is expected to provide statistical support to clinical studies within Teva Global R&D. The support includes, but not limited to, study designs and data analyses. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks. A Principal Statistician should be a strong individual contributor, beginning to demonstrate leadership qualities and creative and strategic thinking. A Principle Statistician must have excellent written and oral communication skills. 
Travel Requirements: Low 

Essential Duties & Responsibilities: 
Provides study design input and consultation for clinical endpoint assessment and sample size planning 
Writes, or oversees the writing of, statistical analysis plans and validation plans 
Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of Teva products 
Conducts analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses 
Responsible to develop the dataset specifications for ADaM datasets 
Responsible for the QC of SDTM and ADaM datasets as well as tables, listings and graphs to support the CSR, submissions and publications 
Responsible to review study data to identify data issues that may impact the validity of the study and corresponding statistical analyses 

Position Requirements: 
Education Required: Ph.D./MS in Statistics/Biostatistics (or related field) 
Experience Required: A minimum of 5 years of related experience 
Experience Preferred: 
Specialized or Technical Knowledge Licenses, Certifications needed: 
Functional Knowledge: 
Company/Industry Related Knowledge: 

Job-Specific Competencies: 
Excellent presentation and written communication skills 
Ability to communicate with non-statisticians to interpret statistical findings 
Good organizational and problem-solving skills 
Demonstrated project and technical leadership qualities, and creative and strategic thinking required 
Ability to program using SAS, knowledge of R is beneficial 
Knowledge of relevant ICH, FDA and CHMP guidelines 
Knowledge of CDISC requirements including SDTM and ADaM 

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