Manager, Statistical Programming
About The Position
Bristol Myers Squibb is seeking a Manager, Statistical Programming to provide programming expertise to clinical project teams. This role supports the development, regulatory approval, and market acceptance of company products by designing, developing, and implementing technical solutions for integrating, analyzing, and reporting clinical data. The position involves performing programming validation to ensure the quality of analysis datasets and outputs, providing programming support for project teams (including strategy, standards, specifications, and programmed analysis), and supporting clinical project teams and vendors in complying with regulatory requirements and SOPs. The role also includes developing, validating, troubleshooting, and maintaining statistical programs and utilities, and supporting electronic submissions preparation and review. Key responsibilities also involve reviewing planning documents (statistical analysis plan, data presentation plan, data review plan) for alignment with project objectives and requirements, assessing these documents, communicating issues and risks, and collaborating with vendors on project standards and specifications.
Requirements
- Master’s degree or foreign equivalent degree in Information Technology, Statistics, Biostatistics, Computer Science, or related field, and two (2) years of related work experience as a Biostatistician or related occupation.
- Two (2) years of experience with/in: Statistical programming within pharmaceutical clinical development
- Two (2) years of experience with/in: Reviewing statistical analysis plans, data presentation plans, or data review plans
- Two (2) years of experience with/in: Creating SAS programs to generate TFLs
- Two (2) years of experience with/in: Applying clinical data structures including Clinical Data Interchange Standards Consortium (CDISC) and relational databases
- Two (2) years of experience with/in: Using software tools and applications including XML to produce analysis datasets
- Two (2) years of experience with/in: Processing upstream statistical data including eDC and SDTM
- Two (2) years of experience with/in: Providing outputs to meet downstream requirements including ADaM, Data Definition Table, and e-submissions
- Two (2) years of experience with/in: Leveraging statistical terminology, clinical trial methodologies, protocol designs, and global regulatory standards
- Two (2) years of experience with/in: Working with Linux operating system.
Responsibilities
- Provide programming expertise to clinical project teams to support the development, regulatory approval, and market acceptance of company products.
- Design, develop, and implement technical solutions to integrate, analyze, and report clinical data.
- Perform programming validation to ensure quality of analysis datasets and programming outputs.
- Provide programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis.
- Support clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, Standard Operating Procedures (SOPs), and work practices.
- Develop, validate, troubleshoot, and maintain statistical programs and utilities in accordance with pre-defined specifications and standards.
- Support electronic submissions preparation, and review.
- Review planning documents to ensure alignment with project objectives, programming assumptions, requirements, and activities.
- Communicate issues and risks and contribute to its remediation.
- Assess key planning documents including statistical analysis plan, data presentation plan, and data review plan.
- Collaborate with vendors on project standards, programming conventions, programming specifications and file transfers.
Benefits
- Annual discretionary bonus
- Healthcare: Medical, pharmacy, dental, and vision care
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
- Work-life benefits: Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
- 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
