POSITION SUMMARY:

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

Salary range:

Premium (NY and CA only): $170,000 - $200,000

National $153,000 - $180,000

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

WORKING CONDITIONS:

PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.