Senior Manager, Biostatistics
Bristol Myers Squibb
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.
Job description
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
- 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.
Qualifications & Experience
- 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 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.
Requirements
- Fresh PhD with 3+ years' experience or MS with 5+ years' experience in statistics or biostatistics or related scientific field
- Clinical trials, drug development, pharmaceutical industry or healthcare experience
- Proficiency in scientific computing/programming (SAS, R or Python)
- 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
- Ability to work successfully within cross-functional teams
- Ability to 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
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Flexible Time Off
- Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.