Location: Emeryville, CA
Department: Clinical Development - Fintepla
The Director, Biostatistics provides statistical support and leadership for clinical development and medical affairs, and has responsibility for strategic and operational activities. This role is also responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent serves as senior statistics specialist, with demonstrated leadership within statistical methodology or application. This position will report to the Vice President of Biometrics.
- Responsible for leading the Biostatistics platform for assigned projects in ensuring effective, timely, high quality and compliant management and delivery of project goals and Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as Translational Medicine research efforts
- Actively participate in cross‐functional teams and other functional areas to ensure timely project deliverables; maintains consistently high performance standards and quality of work and ensure all clinical development programs meet scientific, regulatory, quality and commercialization requirements
- Provide strategic thinking and statistical expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a statistical perspective to the creation of the Clinical Development Plans
- Interact with department leadership to determine department goals and resource allocation.
- Ensure project teams have high-quality statistical support for creation of clinical development plans (CDP), study design, and operational aspects.
- Lead all aspects of statistical reporting and ensure compliance with data submission guidelines, including review of documents, such as SAP, Key Results, CSR, and coordinated summaries.
- Ensure statistical designs, data collection, analysis methodologies and processes to address the objectives of clinical studies and programs clearly and robustly.
- Lead development and optimization of statistical processes focusing on efficiency and quality, while maintaining or exceeding industry best practices.
- Work with senior management to ensure statistical representation in key project decisions and regulatory meetings and serve as departmental representative on corporate-wide teams.
- PhD in Statistics or relevant field with 10+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas
- Work in a fast-paced environment, with excellent judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards
- Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees
- Detailed knowledge of clinical development with the ability to innovatively apply technical principles, theories and concepts to drug development leading to regulatory approvals
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
- Excellent verbal and written communication, and presentation skills.
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)
Fit with Zogenix culture
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with Zogenix’s Core Values
- Excitement about the vision and mission of Zogenix