Biostatistics Consultant

POSITION SUMMARY:

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

This will be a remote opportunity. 

ESSENTIAL DUTIES AND 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

KNOWLEDGE AND SKILL REQUIREMENTS:

• Ph.D. in Biostatistics, Statistics, or Mathematics with about four years of experience in support of clinical studies in a pharmaceutical or biotech industry setting.
• Comprehensive and detailed knowledge of statistical experimental design, analysis and clinical trial requirements
• Demonstrated proficiency with statistical software such as R, SAS
• Experience with eCTD submissions; Understanding 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