Job Description & Scope
Job description 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 . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets 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 revi e w 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 programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e. g. CD I SC 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 d ata 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 environm ent 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) 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 If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integr
