SR. DIRECTOR, BIOSTATISTICS / DATA MANAGEMENT - SAN DIEGO, CALIFORNIA
Manage an efficient statistics and data management function to support the discovery, clinical development and regulatory needs of company. This position will be responsible for planning and performing statistical analysis for clinical trials -evaluation of drugs. Which includes the design, implementation, analysis and reporting of clinical trials. Participate in the preparation of INDs, NDAs, and other reports required by management and regulatory agencies for drug programs. Manage a staff of 4-6 direct reports.
Respond to queries posed by medical monitors, senior management, and regulatory agencies. Responsible for providing statistical advice to clinical research, data management, and regulatory staff. Provide vision, management and technical expertise to build a core statistics and data management function capable of supporting discovery and clinical development. Ensure that company has the necessary capabilities and staff to operate a core in-house data management function and effectively integrate in-house and outsourced data management effectively to successfully and efficiently support regulatory requirements.
The primary focus of this position is on clinical trials methodology and data, but will oversee outsourcing of selected data management and statistical projects. Ensure appropriate selection vendors. Monitor performance. Ensure appropriate quality and audits. Responsible for the statistical design of clinical trials, ensuring the design of CRFs meet the statistical criteria of the protocol. Participate in investigator's meetings, deadline driven with timely reporting of written analysis plan. Involved in preparation of BLA ,NDA, MAA for submission.
Write statistical sections of the clinical research reports.
This position will provide statistical, clinical trial methodological, and regulatory input to study teams: trial design, sample size estimation, randomization, statistical methods for . Responsible for the analysis of clinical trial data, provide statistical input into the reporting of clinical trial results, and clearly communicate statistical results and concepts to non-statisticians. Provide input into statistical and data management processes. Participate in interactions with regulatory agencies as required. Contribute ideas for more efficient and effective design and analysis of the clinical trials. Appoint, hire, train and manage all department staff by setting clearly defined goals, timelines, and reviewing the progress.
Ph.D. in Statistics/Biostatistics with at least 5 years of related experience or MS with minimum of 5 years related experience in pharmaceutical/biotech setting. Broad experience in clinical statistics, data management are required. SAS programming is highly desirable. Position requires excellent and proven leadership skills, team skills, written and oral communication skills. Strong ability to handle multiple projects simultaneously. Oncology experience is preferred. Capable of representing the Company in statistical discussions with the FDA and other major regulatory authorities worldwide. Email Resume in MS WORD format to: Resumes at EliteStaffingsvc.com
Elite Staffing Services, Inc.
Elite Recruiting Services, Inc.
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