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Statistical Programming Leader
1 month ago
Unlock New Opportunities
Bristol Myers Squibb is a global biopharma leader that transforms patients' lives through science. As an Associate Director of Statistical Programming, you will play a critical role in leading clinical project teams and driving the development, regulatory approval, and market acceptance of our products.
About the Role
This position requires functional expertise and leadership to lead statistical programming teams and provide technical solutions for integrating, analyzing, and reporting clinical data. You will drive the development and implementation of innovative strategies and technologies for clinical trial programming, collaborate with Global Biometrics & Data Sciences (GBDS), external vendors, and cross-functional development teams.
Responsibilities
- Provide 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.
- Drive the development and implementation of innovative strategies and technologies for clinical trial programming.
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
- Lead the electronic submission preparation and review.
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications).
- Review planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensure clarity and completeness of programming assumptions and requirements; Assess document robustness and impact on programming activities.
Requirements
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
- At least 10 years of programming experience in industry, including support of significant regulatory filings, and minimum 5 years of experience in managing technical professionals in a regulated environment.
- 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 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.
About Us
We offer a competitive salary range of $180,000 - $250,000 per year, depending on your location and experience. Bristol Myers Squibb 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.
How to Apply
If you are a motivated and experienced professional looking for a new challenge, please submit your application with your resume and cover letter. We look forward to hearing from you.
