Sr. Director, Biometrics
San Jose, CA
Position Description and Responsibilities
The Executive Director of Biometry will be responsible for day-to-day biostatistical, statistical programming, data management, and clinical programming operations of the company. They will assist the President/CEO with developing, implementing, and maintaining strategies that meet the goals of the company. This individual must be a proactive team player, dedicated to enhancing the quality of services provided to clients, have demonstrated leadership ability, and be skilled in program development and problem-solving.
The successful candidate will provide leadership in the statistical, programming, and data management services required for the rapid clinical development of our clients’ program goals. He/She will play a leading role in managing statistical activities including timelines, resource planning, and statistical deliverables related to clinical development projects. It is necessary to have a clear understanding of the therapeutic area under investigation including approved competing products in the market. He/She will identify and provide solutions to statistical issues related to overall clinical development projects and individual studies. This role is responsible for preparing/reviewing study protocols, statistical analysis plans, study reports, and manuscripts as well as preparing/reviewing submission documents to regulatory agencies and participating in meetings with regulatory agencies. He/She will interact and manage activities outsourced to contract resources, as well as develop and improve internal infrastructure, including development of standard operating procedures. The ideal candidate will have strong statistical skills, is able to work without supervision, and can provide "hands-on" statistical leadership to projects and perform the required statistical activities. The Executive Director assumes overall responsibility for the successful execution of the projects assigned.
The Executive Director of Biometry will expand and broaden the scope of statistics in the area of pharmaceutical research, provide guidance in statistical analyses methodology, and perform statistical programming, design, and analyses for multiple clinical trial projects. The Executive Director will direct and supervise project team members in all aspects of design and statistical analyses and reporting on clinical research. This includes providing consultation with clients regarding the conduct of experiments, clinical trials, statistical methodology, and regulatory issues. He/She will interact with domestic and foreign regulatory agencies for projects and programs in the support of new product development, for domestic and international regulatory submissions, and in the maintenance and growth of existing products.
- Oversee all data management and biostatistical operations at the company.
- Manage all resources associated with the data management and biostatistical operations of the company.
- Provide project oversight, including supporting Project Managers and the project team, as well as issue resolution, as needed.
- Provide support to Business Development in proposal development, budget preparation, and client presentations.
- Clinical Program strategic planning: Plan for FDA interactions, sequencing of studies in overall development plan, resource allocation, and budgeting.
- Design of study protocols: Propose study designs and formulate endpoints in a wide variety of therapeutic areas (often involves consideration of regulations and research of historical studies). Provide pre-specified analysis methodologies, sample size planning, and CRF design.
- Information systems development: New industry technologies will be implemented to ensure study databases meet our clients’ ISS and ISE structure standards. Analysis generation software will follow SOPs for validation and consistent design to maximize efficient use across the range of clinical studies.
- Study analysis generation: Provide accurate and timely interim validation of the statistical output for the final report.
- Study report production: Reports must meet FDA/ICH guidance for content, be accurate, meet corporate standards for consistent content, and be delivered in timely fashion to meet project deadlines.
- Regulatory filings: Study protocols, study reports, and other regulatory documents must meet FDA content guidelines.
- Management of internal and external staff: Identify clinical information resources required to meet new project demands. Provide technical guidance to outside contractors performing studies for our clients. Write analysis specifications for programmers and provide QA review of programmed analyses. Develop and maintain SOPs for staff operations.
- Oversee working with Quality Assurance to update operational SOPs.
- Participate in departmental process development initiatives by working closely with DM Managers/Project Managers/Statisticians, and other staff as required.
- Review statistical programs for adherence to the protocol and accuracy.
- Oversee hiring and training and daily management of the Statistical Programming and Biostatistics staff.
- Maintain awareness of global regulatory developments relevant to design and analysis of clinical trials and ensure that colleagues are kept informed.
- Contribute to professional activities (meetings, publications) to develop profile of the company as a provider of statistical services.
- Working knowledge of non-sequential and sequential clinical trial methodologies, advanced statistical theory and methods including specific knowledge of experimental design, analysis of variance and linear models, survival analysis, categorical analysis, multivariate analysis, robust estimation, and nonparametric techniques.
- Responsible for the statistical input provided by the group to all major documents, including clinical development plans, protocols, clinical study reports, and summaries of clinical safety and efficacy.
- Advise statisticians on technical issues associated with the design, performance, and analysis of clinical trials.
- Provide review and guidance to statisticians on statistical aspects of all FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee Meetings.
- Maintain comprehensive knowledge of theoretical and applied statistics and regulatory guidelines regarding clinical trial analysis and reporting. Apply new statistical procedures to projects as appropriate.