Manager, Statistical Programming

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Employer: Bristol-Myers Squibb Company Job Title: Manager, Statistical Programming Location: 3551 Lawrenceville Road, Princeton, NJ 08540 Wage Range: $113,639.00 - $148,610.00 Bristol-Myers Squibb Company is hiring a(n) Manager, Statistical Programming (in Princeton, NJ). Duties: 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. 100% telecommuting permitted. Requirements: Employer will accept a 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. Must have two (2) years of experience with/in: • Statistical programming within pharmaceutical clinical development; • Reviewing statistical analysis plans, data presentation plans, or data review plans; • Creating SAS programs to generate TFLs; • Applying clinical data structures including Clinical Data Interchange Standards Consortium (CDISC) and relational databases; • Using software tools and applications including XML to produce analysis datasets; • Processing upstream statistical data including eDC and SDTM; • Providing outputs to meet downstream requirements including ADaM, Data Definition Table, and e-submissions; • Leveraging statistical terminology, clinical trial methodologies, protocol designs, and global regulatory standards; and • Working with Linux operating system. Additionally, employees are eligible for an annual discretionary bonus, and benefits including Additionally, employees are eligible for an annual discretionary bonus, and benefits including healthcare, leave benefits, and retirement benefits. BMS operates a pay-for-performance compensation philosophy and your total compensation may vary based on...