Senior Manager, Statistical Programming
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Position Summary
The Senior Manager of Statistical Programming provides comprehensive programming expertise to clinical project teams, leading statistical programming teams and supporting the development, regulatory approval, and market acceptance of Bristol Myers Squibb products. The role is primarily responsible for designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data, collaborating effectively with Global Biometrics & Data Sciences (GBDS), external vendors, and cross‑functional teams. The Senior Manager also supports and leads improvement initiatives, proactively plans, implements, and identifies risks, and manages functional responsibilities when applicable.
Key Responsibilities
- Provides comprehensive programming leadership and support to clinical project teams and vendors, deploying 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 and supports the electronic submission preparation and review.
- Develops unambiguous and robust programming specifications (e.g., ADaM specifications).
- Reviews key planning documents (statistical analysis plan, data presentation plan, data review plan) to align with project objectives, ensuring clarity and completeness of programming assumptions and requirements; assesses document robustness and impact on programming activities.
- Communicates proactively and effectively around issues and risks, contributing to remediation.
- Identifies, leads, and supports opportunities to enhance processes and technology, improving the overall efficiency and quality of programming deliverables.
Managerial Responsibilities (if applicable)
Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, ensuring increasing capabilities within GBDS.Conducts objective setting, performance check‑ins, and year‑end discussions in compliance with BMS policies, aligning objectives, feedback, and performance evaluation with the manager.Provides real‑time coaching and feedback, holding staff accountable for quality and timeliness of programming activities and ensuring compliance with training requirements.Communicates with the manager regarding promotions, performance concerns, and retention risks.Builds and maintains a network with stakeholders and peers to ensure cross‑functional strategies interlock, achieving results.Minimum Qualifications
Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences required.At least 8 years of programming experience in industry, including support of significant regulatory filings.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 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 upstream data (e.g., multiple data forms, workflows, eDC, SDTM) and 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.Additional Information
Seniority level : Mid‑Senior level
Employment type : Full‑time
Job function : Design, Art / Creative, and Information Technology
Industry : Pharmaceutical Manufacturing
Equal Employment Opportunity Statement
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 Visit careers.bms.com / eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider employment for qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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