Bristol-Myers Squibb Company

Principal Analyst II

Location
Princeton, NJ, US
Posted
Apr 13, 2018
Ref
R1120981
Required Education
Doctorate/PHD/MD
Position Type
Full time

Wallingford Transition

Global Biometric Sciences
Statistical Programmer

Purpose:

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 GBS, with external vendors and members of cross-functional development teams. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.

Primary Responsibilities:

• Communicates effectively with GBS project and functional leadership concerning project issues (e.g. data, technical, timelines).
• Ensures alignment with Planning & Execution Lead with regard to priorities and scope of work assignments. Proactively, informs Planning & Execution Lead of issues/risks to the project and potential remediations.
• 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 and global clinical trial programming.
• Reviews key planning documents (e.g., 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.
• 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 GBS and the broader R&D organization. Provides timely and effective communication to project team members, highlighting GBS goals and priorities, ensuring work efforts parallel departmental objectives.
• Provides leadership for ensuring quality of GBS 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 GBS and across R&D. 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.

Impact:

Statistical programmers are a key contributor to the planning and production of high quality programmed deliverables that support the accurate analysis and interpretation of clinical data. By effectively managing all aspects of analysis programming, statistical programmers facilitate better understanding of our assets, improved development decisions and an increased likelihood of regulatory and market success. Statistical programmers enable GBS to effectively leverage contracted services, a significant portion of our A&R capacity, through the development of unambiguous and accurate work specifications and the efficient acceptance of vendor deliverables. As members of multiple project teams, statistical programmers ensure consistent and compliant practices across our GBS teams through the uniform application of standards and strict adherence to regulatory requirements, guidance and corporate and departmental SOPs and work practices.

Education / Experience

• Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred
• Minimum of 4 years clinical/statistical programming experience within pharmaceutical clinical development
• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as relates 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 leading 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

Primary Stakeholders:

Stakeholder Area of Focus
Development Team • Reviews key documents for clarity and completeness of programming assumptions and requirements
• Attends IPT and Data Team meetings as needed
GBS Lead • Matrixed reporting relationship (e.g. assignments, performance input)
• Identification and management of issues and risks
GBS Planning & Execution
Lead • Project management (e.g. work assignments & status)
• Specifications for out-sourced work & deliverable acceptance
• Identification and management of issues and risks
GBS Project Team • Development of programming strategies and standards for project
• Program outputs to support analysis and interpretation of clinical data
• Contributes to GBS team discussions
• Identification and management of issues and risks
Vendors • Communication and/or clarification of project standards, programming strategies and conventions, specifications, etc.
• File transfers
• Vendor deliverables review and acceptance
• Feedback on vendor performance