Director of Biostatistics
Location: Burlingame, CA
Position Type: Full time
General Position Job Summary/Purpose
Responsible for designing, planning and conducting of pre-clinical and clinical studies for a development molecule candidate. Maintains departmental infrastructure and procedures and ensures adherence to the company standards, and all applicable regulations and guidelines. Responsible for providing statistical expertise/leadership to pre-clinical research and/or clinical development projects. Make recommendations with regards to the strategic aspects of pre-clinical and clinical studies as well as oversight of biostatistics activities.
Role and Responsibilities
- Ensure that proper activities are undertaken for the development projects in timely fashion and with high quality to meet Corvus corporate objectives.
- Research and gain in-depth understanding of the responsible compounds and their development pathways, as well as the competitive landscape of the indications.
- Collaborate in interdepartmental and scientific activities, especially on protocol design (author or supervisor for the statistical methods section and generate study randomization), including, as appropriate, interim analysis strategy for the purpose of futility and/or early claim of efficacy and ensuring data and study integrity.
- Generate statistical analysis plan for responsible protocols (including Mock displays of analysis results)
- Provide statistical input for NDA submissions and in response to FDA queries.
- Provide statistical support to the pre-clinical research projects, including pharmacological and translational research projects in study design and analysis.
- Lead drug development as well as statistical technique development projects.
- Provide support to presentations and publications based on Corvus studies.
- Review case report forms to ensure that protocol objectives are met and project standards are maintained.
- Responsible for ensuring compliance with departmental and company goals.
- Effectively communicate relevant updates to all team members involved.
- Works with other senior managers to establish strategic objectives and plans for research and development programs.
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company objectives.
- Directs and controls the activities of a broad functional area through partnership with cross-functional department managers within the company.
- Manage direct reports, and is responsible for ensuring and overseeing the work of others including mentoring of staff on all assigned clinical studies
Qualifications and Education Requirements
- Demonstrated in-depth knowledge of applied statistics and extensive experience in the application of statistics to (pre-)clinical researches.
- Demonstrated ability to independently research and develop statistical methodologies.
- Be able to apply judgment and professional expertise independently.
- Must have strong negotiation skills with external vendors and company management in order to influence senior leaders regarding matters of significance to the company.
- Ph.D. in (Bio)statistics or closely related discipline with a minimum of 10 years of experience in pharmaceutical and biotech industry.
- Experience in the design and analysis of late stage oncology clinical trials including stratification, subset analysis, handling of multiple endpoints and hierarchical analysis.
- Previous experience with all phases of clinical research and statistical technique development.
- Leadership in resource allocation, budget forecasting, project prioritization, and handling multiple tasks simultaneously.
- Excellent teamwork and collaboration skills.
- Familiar with SAS programming.
- Prior management/supervisory experience, management style that delegates to and empowers employees, and fosters teamwork
- Ability to coach, manage, and provide feedback.
Proficient with R software and programming.
Good skills in presentation to large audience
Join our Team
Local candidates only please! If you are interested, please submit a cover letter and your resume to email@example.com