Senior Manager - Statistical Programming

Bristol Myers Squibb • Princeton, NJ

1d

About The Position

Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams, lead statistical programming teams, and support the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. The role is primarily responsible for designing, developing, and implementing technical solutions to integrate, analyze, and report clinical data. Senior Managers build collaborative relationships and work effectively within Data & Quantitative Sciences (DQS), with external vendors, and with cross-functional development teams.

The role also supports improvement initiatives by proactively planning and implementing changes, identifying issues and risks, developing remediation strategies to facilitate decision-making, and leading or supporting change management activities such as communication, training, and stakeholder engagement.

Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences.
• At least 6 years of industry programming experience, including support of significant regulatory filings.
• Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in clinical data analysis and submission.
• Broad expertise in statistical programming and developing computing strategies.
• In-depth understanding of clinical data structures, such as CDISC standards, and relational databases.
• Demonstrated proficiency using SAS to produce analysis datasets and tables, figures, and listings (TFLs), and using other software tools and applications such as MS Office, XML, and Pinnacle 21.
• Demonstrated ability to process upstream data, such as multiple data forms, workflows, eDC, and SDTM.
• Demonstrated ability to provide deliverables meeting downstream requirements, such as ADaM, TFLs, and e-submission components.
• Demonstrated ability to work in a team environment with clinical team members.

Responsibilities

• Provide programming leadership and support to clinical project teams and vendors, including deploying programming strategies, standards, specifications, and programmed analyses that comply with regulatory requirements, SOPs, and work practices.
• Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
• Lead or support electronic submission preparation and review.
• Develop clear and robust programming specifications, such as ADaM specifications.
• Review key planning documents, including statistical analysis plans, data presentation plans, and data review plans, to align with project objectives and ensure programming assumptions and requirements are clear and complete.
• Assess the robustness of planning documents and their impact on programming activities.
• Communicate proactively and effectively about issues and risks and contribute to remediation.
• Identify, lead, and support opportunities to enhance processes and technology.
• Lead and support change management activities, including communication, training, and stakeholder engagement.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior