Manager, Statistical Programming

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 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 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 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 derived analysis datasets and TFLs Have in-depth understanding of clinical data structure e g CDISC standards and relational database Have worked on Japan PMDA submissions proficient in creating eSub package aCRF SDRG define xml 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 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 Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science TM every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations