Senior Manager, Biostatistics

Web-atrio; San Diego (CA); On-site; USD 150,000 - 200,000; Full time

Job description

Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary

The Senior Manager of Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead and other cross-functional team members.

Key Responsibilities

1. Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
2. Authors and/or reviews protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents with minimum supervision.
3. Performs and/or validates statistical analyses, advising ways to maximize clarity of data display.
4. Communicates results to cross-functional teams, providing data interpretation in study documents such as clinical study reports and publications.
5. Translates scientific questions into statistical terms and statistical concepts into layman terms.
6. Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverables.
7. Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
8. Continually enhances knowledge of drug development process, regulatory and commercial requirements.
9. Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
10. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

Qualifications & Experience

1. Fresh dose of experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
2. Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
3. Good interpersonal, communication, writing and organizational skills.

Ability to:

1. Learn regulatory requirements & clinical trial design, data analysis and interpretation.
2. Work successfully within cross-functional teams.
3. Organize multiple work assignments and establish priorities.

Experience in standard and advanced statistical methods is preferred. Good understanding of regulatory requirements & clinical trial design is preferred.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.