Associate Director, Biostatistics
Job Responsibilities:
- Oversee execution of the statistical components of clinical studies by CROs and independent contractors. Manage on-time and quality delivery of CRO generated analyses results.
- Operate with minimal supervision to lead clinical trials from Phase I-IV
- Oversee development of various oncology-focused studies.
- Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers. This position will manage external/internal statisticians and statistical programmers.
- Collaborates with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting
- Author or oversee the development of statistical analysis plans
- Promote teamwork, quality, and innovation. Ensure project team compliance with SOPs and departmental standards.
- Reviews and approves study database specifications, data management plans, data transfer plans, CDISC and ADaM specifications, and ensures reviews as needed by other appropriate function
- Communicate with FDA and other regulatory contacts
Education/Qualifications:
- D. or Master's Degree in Statistics, Mathematics, Biostatistics or a related discipline.
- 7+ years of experience in Clinical Trials
- Experience managing outside vendors (CRO's, etc.
Offers:
- Competitive package
- Stock options
- Health/Dental/Vision
- 401(k) plan * Flexible vacation policy
- Exciting opportunity to work with a talented and fun team