Senior Manager - Statistical Programming

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.

Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Data & Quantitative Sciences (DQS), with external vendors and members of cross-functional development teams.

Senior Managers of Statistical Programming also support improvement initiatives. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement).

Project Responsibilities:

· Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices

· Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards

· Leads / Supports the electronic submission preparation and review

· Develops unambiguous and robust programming specifications (e.g. ADaM specifications)

· Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities

· Communicates proactively and effectively around issues and risks and contributes to its remediation

Improvement Responsibilities:

· Identifies, leads, and supports opportunities to enhance processes and technology

· Communicates proactively and effectively around issues and risks and contributes to its remediation

Minimum Requirements:

· Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required

· At least 6 years programming experience in industry including support of significant regulatory filings

· For US positions: US military experience will be considered towards industry experience

· Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data

· Broad expertise in statistical programming and in developing computing strategies

· In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases

· Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)

· Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)

· Demonstrated ability to work in a team environment with clinical team members

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.

Compensation Overview:

Brisbane - CA - US: $167,120 - $202,508
Cambridge Crossing: $167,120 - $202,508 
Princeton - NJ - US: $145,320 - $176,099 
Seattle - WA: $159,850 - $193,702


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:

…