Senior Biostatistics Lead – Clinical Trials & Submissions

Bristol-Myers Squibb Co; Princeton (NJ); Vor Ort; USD 164.000 - 199.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Wellbeing support

Retirement plan

Medical insurance

Dental insurance

Vision insurance

Flexible time off

Paid holidays

Vacation days

Volunteer days

Zusammenfassung

Bristol Myers Squibb in Princeton, NJ seeks a Senior Manager, Biostatistics to lead statistical aspects of trial design, analysis planning and regulatory submissions within cross-functional teams. You will translate scientific questions into statistical plans, review SAPs, and ensure high-quality deliverables in line with regulatory expectations.

We value experience with clinical trials, proficiency in SAS/R/Python, and strong communication skills to present complex results to diverse audiences.

Qualifikationen

• Fresh PhD with 3+ years’ experience or MS with 5+ years’ experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
• Proficiency in 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.

Aufgaben

• Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
• 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.
• 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 statistical methodology and how it is appropriately applied in trial 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 DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS.

Kenntnisse

Biostatistics

Clinical trials

SAS

R

Python

Cross-functional collaboration

Communication skills

Ausbildung

PhD in statistics/biostatistics

MS in statistics

Tools

SAS

R

Python

Jobbeschreibung

Bristol Myers Squibb in Princeton, NJ seeks a Senior Manager, Biostatistics to lead statistical aspects of trial design, analysis planning and regulatory submissions within cross-functional teams. You will translate scientific questions into statistical plans, review SAPs, and ensure high-quality deliverables in line with regulatory expectations.

We value experience with clinical trials, proficiency in SAS/R/Python, and strong communication skills to present complex results to diverse audiences.