Role at a glance
- Job function
-
AI & Data Data Analytics
- Salary
- Not Disclosed
- Location
- TS, Indiana, United States
- Work arrangement
- Hybrid
- Employment
- Full-time
- Experience
- 5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development
- Education
- Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred
Spotted an issue?
We’ll check it against the original posting.
Role Summary
Provides statistical programming expertise to clinical project teams, supporting the development, regulatory approval, and market acceptance of BMS products. The role designs, develops, and implements technical solutions for integrating, analyzing, and reporting clinical data.
What You'll Do
- Develop programming strategies, standards, specifications, and programmed analyses for project teams.
- Review planning documents, including protocols and statistical analysis plans, for alignment and clarity of programming requirements.
- Coordinate with vendors on project standards, specifications, and file transfers, and support acceptance of vendor deliverables.
- Communicate project issues and priorities with DQS leadership and cross-functional team members.
- Promote quality and regulatory compliance in deliverables, and contribute to process, standards, and tools improvement.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development. Significant knowledge of SAS (Base, Stat, and Graph components) and general computing related to clinical drug development; knowledge of drug development, clinical trial methodology, statistics, and global regulatory requirements; ability to work across teams, adapt, organize multiple assignments, and communicate verbally and in writing.
Preferred
- Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred
- Oncology Experience preferred
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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.
Position Summary
Statistical programmers provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of BMS products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Statistical programmers develop collaborative relationships and work effectively within DQS, with external vendors and members of cross-functional development teams. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.
Duties/Responsibilities
- Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis. Drives the development and implementation of innovative strategies and technologies for flexible clinical trial programming.
- Reviews key planning documents (e.g., protocol, statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
- Supports the development of unambiguous and robust programming specifications for internal and external programming work.
- Communicates effectively with DQS project and functional leadership concerning project issues (e.g. data, technical, timelines).
- Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers. When necessary, provides technical guidance to vendors supporting analysis and reporting (A&R) work. Provides support for acceptance of vendor deliverables.
- Builds successful partnerships and seamless interfaces within DQS and the broader Global Drug Development (GDD) organization. Provides timely and effective communication to project team members, highlighting DQS goals and priorities, ensuring work efforts parallel departmental objectives.
- Provides leadership for ensuring quality of DQS deliverables by consistently applying A&R standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
- Identifies opportunities for increased efficiency and consistency within DQS and across GDD. Contributes to globalization, improvement and standardization of processes, standards, and tools.
- Contributes to the technical evaluation of candidates and supports their successful integration into the organization.
Degree Requirements:
- Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred
Experience Requirement:
- 5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development
- Oncology Experience preferred
Key Competency Requirements:
- Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as related to clinical drug development.
- Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
- Ability to work successfully within cross-functional teams leads to successful global regulatory filings and approvals.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Ability to organize multiple work assignments and establish priorities.
- Excellent verbal and written communications skills
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
About the company
Bristol Myers Squibb
Large Enterprise
Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a focus on oncology, immunology, and cardiovascular health, the company leverages advanced science and technology to create transformative therapies that address critical unmet medical needs. Operating in more than 70 countries, Bristol Myers Squibb emphasizes collaborative efforts and strong partnerships in research and development to drive advancements in healthcare and improve patient outcomes worldwide.