Principal Biostatistician, San Diego, CA

A Biostatistician is required for a growing pharma client in San Diego, CA

Essential Duties and Responsibilities:
* Performs and reports the results of appropriate statistical analyses
* For assigned clinical development projects, provides statistically sound scientific methodology in experimental design and data analysis to meet project objectives and relevant requirements from regulatory agencies
* Reviews or authors statistical analysis sections of protocols, statistical analysis plans, study reports, regulatory documents, or scientific publications; generates or reviews study randomization, sample size/power estimations
* Participates in interaction with clinical development, medical writing, regulatory affairs, and regulatory agencies
* Reviews case report forms to ensure that protocol objectives are met and project standards are maintained
* Develops statistical programs or oversees their preparation as needed to perform pre-specified or ad-hoc analyses with corresponding data displays
* Supplies statistical input for regulatory submissions and in response to FDA questions
* Oversees all aspects of preparation and execution of statistical analysis plans to ensure efficiency and quality outputs
* Evaluates study results, in collaboration with other relevant scientific disciplines, to provide appropriate interpretation of data and sound study conclusions
* Collaborates with programming and data management to ensure data collection and reporting is done in accordance with relevant SOPs, GCPs, and regulatory requirements
* Maintains currency with respect to FDA and ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development
* Becomes familiar with the disease states and competitors in order to enhance the level of customer focus and collaboration
* Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data
* Assists the organization in the evaluation of clinical, statistical, programming, and data management vendors
* Assists the organization in identifying consultants or other external talent, where needed
* Assists in the development of SOPs and work procedures for biostatistics, statistical programming, and data management
* Mentors junior statisticians

Education:
* Ph.D. in Statistics/Biostatistics with at least 5 years of clinical trials experience or M.S. in Statistics/Biostatistics with at least 9 years of clinical trials experience, preferably in a pharmaceutical industry environment

Experience:
* Experience in applying biostatistical methods to the design, analysis, and reporting of pharmaceutical research studies
* Technical knowledge of database structure, relevant computer languages, and statistical software such as SAS, StatXact, S-Plus, and R
* Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development
* Sound knowledge of theoretical and applied statistics
* Sound understanding of regulatory guidelines in a pharmaceutical research setting
* Effective in communication and team collaboration

Other Skills and Abilities:

The following are preferable, but not required
* Direct experience in obesity clinical development
* Regulatory submission of datasets using CDISC, including development of SDTM and ADaM specifications
* Strong SAS programming background including macro development and program validation

To find out more about Real Staffing please visit www.realstaffing.com