Position Summary
Leads the Biostatistics function within therapeutic areas of BMS, providing statistical input to development strategies and implementation plans to support product development or market access objectives globally. Provides expertise and guidance on study design, analyses, strategy, best practices, execution, interpretation, and regulatory submission. Guides and manages statisticians to ensure high-quality, timely deliverables; manages resources, priorities, and standards.
Key Responsibilities
- Manages functional/project budget; allocates resources and sets priorities across compounds/indications.
- Directs/guides statisticians for high-quality, timely deliverables.
- Ensures compliance with BMS processes/SOPs and global/project standards.
- Contributes to Clinical Development Plans, submissions, and post-submission strategies.
- Represents company in global regulatory agency interactions.
- Drives process improvement; contributes to SOPs; provides statistical training.
- Participates in industry technical discussions/professional societies.
- Improves DQS performance; anticipates issues and oversees resolution.
- Acts as matrix team member and scientific/strategic partner on high-level development teams.
- Builds/maintains cross-functional collaborations; supports goal setting/forward planning.
- Fosters inclusiveness and respectful challenge.
Applicable to people managers
- Employee advocate/coach/mentor; empowers and develops team.
- Guides development plans; conducts performance reviews and feedback.
Qualifications & Experience / Skills
- PhD or MS (12+ years) in statistics/biostatistics or related field with clinical trials/drug development/pharma/healthcare.
- Proficiency: SAS, R, or Python; advanced statistical analysis, data manipulation, graphing, simulation.
- Strong communication, writing, organizational, and collaboration/leadership skills.
- Expertise in statistical/clinical trials methodology aligned with regulatory/industry standards.
- Extensive experience with global regulatory interactions; development of resourcing/recruiting strategies.
- People manager: at least 5 years direct/matrix management experience preferred.