Senior Manager - Statistical Programming

Company: Bristol-Myers Squibb
Location: Trenton
Posted on: March 19, 2023

Job Description:

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 rich in diversity. 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 Project Responsibilities:

• Provides 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 develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
• Leads / Supports the electronic submission preparation and review
• Develops unambiguous and robust programming specifications (e.g., ADaM specifications)
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
• Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities:
  • Identifies, leads, and supports opportunities to enhance processes and technology
  • Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable):
    • Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS
    • Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
    • Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
    • Communicates with manager regarding promotions, performance concerns, and retention risks
    • Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Minimum Requirements:
      • Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required
      • At least 7 years programming experience in industry including support of significant regulatory filings
      • For US positions: US military experience will be considered towards industry experience
      • 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 Preferred Requirements:
        • Management experience supervising technical professionals The starting compensation for this job is a range from $126,000 - $159,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits ,please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. - Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. - Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. - This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol-Myers Squibb, Trenton , Senior Manager - Statistical Programming, Executive , Trenton, New Jersey