Director, Biostatistics

Role Summary

The Director of Biostatistics is the lead statistician for all phases of the clinical development studies in collaborating across all functions within clinical development and other functions.

Responsibilities

• Effectively lead all statistics aspect of the study, including author statistics design and analysis plan, mock analysis package (Table, Figures, Listings) and represent statistics in the study team
• Working with study data managers to ensure CRF aligned with protocol and statistical analysis plan, perform UAT for database and other clinical trial modules.
• Worked with study programmers (or CRO programmers) to ensure timely and quality development Mock TFL, dry run, and final TFLs for CSR.
• Good knowledge of FDA and ICH guidelines and participant in eCTD submission, and briefing document development, and other submission as needed

Qualifications

• Ph.D. in Biostatistics, Statistics, or Mathematics with at least ten years of experience in support of clinical studies in a pharmaceutical or biotech industry setting.
• Comprehensive knowledge and experience of statistical designs, analysis and innovative methodology applied to oncology clinical trials
• Demonstrated proficiency with statistical software such as R, SAS
• Experience of leading statistics deliverables in eCTD submissions; Good knowledge of FDA/EU statistical guidelines; experience interacting with regulators
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Strong interpersonal and effective communication (oral and written) skills

Education

• Ph.D. in Biostatistics, Statistics, or Mathematics (as part of Qualifications)

Additional Requirements

• Travel may be required
• Physical demands as described may apply