PROGRAM DIRECTOR BIOMETRICS/BIOSTATISTICS Job in Diamond Bar, California US
Biosense Webster, Inc., a member of Johnson Johnson's Family of Companies, is currently recruiting for a Program Director of Biometrics located in Diamond Bar, CA
Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.
The Program Director of Biometrics will provide general direction for statistical analyses, protocol designs and publication strategy for clinical trials. The successful candidate will manages overall activities of internal staff and consultants for Biostatistics, Programming, Database and Data Management functions. He/She will provide efficient management of statistical analyses to obtain expeditious approvals for global registration trials and for publication purposes and provide oversight for evidence generation and dissemination based on clinical studies.
The Program Director of Biometrics will ensure programming standards are maintained and implemented under the general direction from Director, WW Clinical Operations and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson Johnson, procedures and guidelines. The Program Director of Biometrics will oversee all statistical aspects of clinical trial design, supports evidence and dissemination activities for Clinical Operations.
The successful candidate will recommend and execute innovated trial design, sample size computation strategies and statistical application to interim analysis for all clinical trials. He/She will be responsible for oversight of high level clinical strategies and execution of clinical study activities on global basis. Maximize resource utilization through efficient planning.The Program Director of Biometrics will support the generation and dissemination of clinical evidence (podium presentation, abstract and manuscript) based on clinical data. The Program Director of Biometrics will evaluate candidates, consultants / CROs / Software systems to maximize resource utilization.
The successful candidate will manage and develop direct reports to ensure business continuity and supports other departments within the company as required. He/She will provide statistical consultation for investigator initiated studies, as needed and Interface with FDA and other Regulatory Agencies, as appropriate regarding registration trials. Additionally, the successful candidate will establish/negotiate appropriately competitive timelines for completion of statistical activities. The Program Director will be responsible for ensuring personal and company compliance with all Federal, State, Local and company regulations, policies and procedures for Health, Safety and Environmental Compliance.
The Program Director will be responsible for communicating business-related issues or opportunities to next management level. The successful candidate will be responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. He/She will be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures and perform other duties assigned as needed.
Qualifications
The qualified candidate will have an advanced degree (preferably PhD) in Statistics or related discipline with 4 years of managerial experience and at least 8 years overall experience in the medical device or pharmaceutical field. Experience using SAS/BASE and SAS/STAT in a biomedical or other health related field is required. Competency with life tables and/or Kaplan-Meier analyses is required. Experience with categorical data analysis method and Bayesian methods preferred. Experience in conducting quality of life studies preferred. Competency in understanding and maintaining all aspects of databases for clinical trials is required. Competency in programming for clinical studies and excellent verbal and written communication skills are required. Experience in cardiovascular field is preferred. This position is located in Diamond Bar, CA and requires some travel (global and domestic)
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson Johnson Family of Companies.