Senior Manager, Statistical Programming Lead
5 days ago
Bristol Myers Squibb is seeking a Senior Manager, Statistical Programming to lead our clinical programming team and support the development, regulatory approval, and market acceptance of our products. This role is responsible for designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data.
Key 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.
- Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
- Lead/support the electronic submission preparation and review.
- Develop unambiguous and robust programming specifications (e.g., ADaM specifications).
- Review key 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.
- Communicate proactively and effectively around issues and risks and contribute to their remediation.
- 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 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.
- Management experience supervising technical professionals.
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our company is committed to advancing the treatment of serious diseases and improving the lives of patients and their families. We are a diverse and inclusive organization that values innovation, collaboration, and integrity.
We are an equal opportunity employer and welcome applications from qualified candidates with arrest and conviction records, pursuant to applicable laws in your area. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.
We strongly recommend that all employees be fully vaccinated for COVID-19 and keep up to date with COVID-19 boosters. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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