Bristol Myers Squibb

Manager, Statistical Programming

5 days agoSeattle, WA

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

The Manager, Statistical Programming provides comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Statistical programmers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.

Key Requirements

  • Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
  • Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
  • Support the electronic submission preparation and review
  • Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess impact on programming activities.
  • Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
  • Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
  • Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
  • Independently leads and / or performs programming assignments across multiple projects with minimal supervision
  • Support improvement initiatives

Skills, knowledge, and experience

Minimum Requirements:
  • Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required.
  • 4-7 years programming experience in industry.
  • For US positions: US military experience will be considered towards industry experience.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
  • Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
  • Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
  • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
  • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
  • Have good understanding of regulatory, industry, and technology standards and requirements.
  • Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirements:
  • Minimum of 4 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
  • Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
  • Experience in other software packages (e.g. R)
  • Experience with the Linux operating system

#GBDS

#GBDSProgramming

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.

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