Senior Manager RWE Biostats

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 164,000 - 199,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ is seeking a Senior Manager of Real-World Evidence Biostatistics to lead study design, SAP development, and analysis planning within cross-functional teams.

You will perform and validate analyses, translate questions into statistics, communicate results for study documents, and help advance regulatory submissions while growing technical expertise in real-world evidence.

Qualifications

• Fresh PhD or MS with 2+ years' experience in statistics or biostatistics.
• Proficiency in SAS, R or Python.
• Strong written and verbal communication; teamwork.
• Ability to learn regulatory requirements & clinical trial design.
• Experience in standard and advanced statistical methods preferred.

Responsibilities

• Collaborates in design of RWE study including methodology, data analysis & interpretation, and reporting of study results.
• Authors and/or reviews protocol, SAPs, study reports, associated publications, and other study level specification documents under supervision.
• Performs and/or validates statistical analyses, advise ways to maximize clarity of data display.
• Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Complies with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Continually develops technical knowledge of real-world evidence generation related statistical methodology.
• Continually enhances knowledge of drug development process, regulatory and commercial requirements.
• Develops & advises team members.

Skills

SAS

R

Python

Statistical analysis

Data manipulation

Graphing

Simulation

Communication

Cross-functional teamwork

Education

PhD or MS with 2+ years in statistics/biostatistics

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Senior Manager of RWE Biostatistics is a member of cross-functional teams and contributes to study design, protocol/SAP 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.

Position Summary

• Collaborates in design of RWE study including methodology, data analysis & interpretation, and reporting of study results.
• Authors and/or reviews protocol, statistical analysis plans, study reports, associated publications, and other study level specification documents under some supervision
• Performs and/or validates statistical analyses, advise ways to maximize clarity of data display.
• Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Continually develops technical knowledge of real-world evidence generation related statistical methodology and how it is appropriately applied in study design and data analysis for clear, concise, high-quality results.
• Continually enhances knowledge of drug development process, regulatory and commercial requirement.
• Develops & advises team members.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement, and commitment within GBDS.

Education / Experience Requirements

• Fresh PhD or MS with 2+ years' experience in statistics or biostatistics or related scientific field with clinical trials and/or RWE in pharmaceutical industry or healthcare experience

Key Competency Requirements

• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
• Good interpersonal, communication, writing and organizational skills.
• Ability to:
• learn regulatory requirements & clinical trial design, data analysis and interpretation,
• work successfully within cross-functional teams,
• 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.

Compensation Overview

Princeton - NJ - US: $164,110 - $198,862

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown