Manager, Statistical Programming

🕒 Yesterday

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $113.6k - $148.6k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Health Coverage: 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. • Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees). • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. • Eligibility for specific benefits listed on our careers site may vary based on the job and location.