Bristol Myers Squibb
Pharmaceutical
SeniorProgrammer-Manager,StatisticalProgramming
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optimal for Senior candidates.
“Senior Programmer - Manager, Statistical Programming at Bristol Myers Squibb. Skills: SAS programming, R programming, Clinical data analysis, Regulatory submissions, Statistical programming. Create SAS programs to generate derived analysis datasets and content for tables, listings, and Perform programming validation to ensure quality of analysis datasets and programming outputs. Provides comprehensive programming support for project teams, including development of programming strategies, standar”
What You'll Achieve.
Support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.; Ensure quality of Global Biometric and Data Sciences (GBDS) deliverables.; Transforming patients’ lives through science™
Industry & Context.
Design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data.
Hybrid work model
What They're Looking For.
Must Have
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required., At least 4 years programming experience in industry., 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.
Nice to Have
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
What You'll Do.
Create SAS programs to generate derived analysis datasets and content for tables
and Perform programming validation to ensure quality of analysis datasets and programming outputs
Provides comprehensive programming support for project teams
including development of programming strategies
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 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 across multiple projects with minimal supervision
Support improvement initiatives
How You'll Work.
Team & Collaboration
Provide comprehensive programming expertise to clinical project teams; Develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams; Demonstrated ability to work in a team environment with clinical team members
Process & Methodology
Independently leads and / or performs programming assignments across multiple projects with minimal supervision
Full 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. 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](https://careers.bms.com/working-with-us). **Senior Programmers - Starszy Programista** **** 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. Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. **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 comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis * Support the electronic submission prepara
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