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Uxbridge

    Senior Statistical Programmer - Uxbridge, United Kingdom - Bristol Myers Squibb

    Bristol Myers Squibb
    Bristol Myers Squibb Uxbridge, United Kingdom

    3 weeks ago

    Default job background
    Full time
    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.

    Position Summary

    Provide 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.

    Direct Reports

    None. Possible contractors/leased workers.

    Vendor Oversight

    Yes

    Key Business Partners

    Internal/external stakeholders, project team members, vendors

    Key Responsibilities

  • 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 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; Assesses 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 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.
  • 5 years programming experience in industry recommended.
  • Demonstrated proficiency in using SAS, R or other programming languages 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 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
  • Oncology experience
  • 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
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