Biostatistics Sr Manager

Rigel Pharmaceuticals Inc.; New York (NY); On-site; USD 153,000 - 200,000; Full time

Job summary

This innovative firm is seeking a Biostatistics Sr Manager to lead statistical activities for clinical development studies. In this pivotal role, you will be responsible for authoring statistical design and analysis plans, collaborating across functions to ensure the highest quality of study data. You will leverage your expertise in statistical software and FDA guidelines to navigate the complexities of clinical trials. If you thrive in a dynamic environment and are passionate about making a meaningful impact in the pharmaceutical industry, this opportunity is perfect for you. Join a team that values collaboration and excellence in delivering critical insights to advance healthcare.

Qualifications

• Lead statistician for clinical development studies with comprehensive knowledge of statistical design.
• Proficient in statistical software and FDA guidelines, with strong communication skills.

Responsibilities

• Lead statistical aspects of clinical studies, including design and analysis plans.
• Collaborate with data managers and programmers to ensure quality development of study materials.

Skills

Statistical Analysis

Statistical Software (R, SAS)

Interpersonal Communication

FDA and ICH Guidelines Knowledge

Clinical Trial Requirements

Education

Master's Degree in Statistics or related field

PhD in Statistics or related field

Tools

R

SAS

Job description

Career Opportunities with Rigel Pharmaceutical

A great place to work.

Join Our Team

Are you ready for new challenges and new opportunities?

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 aspects of the study, including authoring the statistical design and analysis plan, mock analysis package (Tables, Figures, Listings), and representing statistics in the study team.
• Work with study data managers to ensure CRF aligns with the protocol and statistical analysis plan; perform UAT for the database and other clinical trial modules.
• Collaborate with study programmers (or CRO programmers) to ensure timely and quality development of Mock TFL, dry run, and final TFLs for CSR.
• Possess good knowledge of FDA and ICH guidelines and participate in eCTD submission, briefing document development, and other submissions as needed.
• Have comprehensive and detailed knowledge of statistical experimental design, analysis, and clinical trial requirements.
• Demonstrate proficiency with statistical software such as R and SAS.
• Have experience with eCTD submissions, understanding of FDA/EU statistical guidelines, and 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.